Product code BZC— Anesthesiology
ARGIS PULMONARY FUNCTION TESTING SYSTEM
- Classification name
- Calculator, Pulmonary Function Data
- Device class
- Class 2
- Regulation
- 21 CFR 868.1880
- Advisory panel
- Anesthesiology
- Total cleared
- 90
- First cleared
- Most recent
Market context for product code BZC
FDA has cleared devices under product code BZC between 1977 and 2024, filed by 60 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2024
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2011
- 2007
- 2005
- 2004
- 2003
- 2002
- 2001
- 2000
Top applicants under product code BZC
Recent clearances under product code BZC
- K240293 — STS
- K183567 — Vyntus/SentrySuite Product Line
- K190853 — Vyntus BODY
- K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
- K162515 — COSMED K5 Wearable Metabolic Technology
- K161295 — MiniBox +
- K150810 — Vyntus / SentrySuite Product Line
- K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE
- K133051 — PULMONE MINIBOX PFT TM
- K102047 — LCI OPTION FOR INNOCOR
- K072323 — MASTERSCREEN & OXYCON CPX
- K052328 — ZAN LUNG-FUNCTION LAB
- K040698 — MASTERSCREEN CPX AND OXYCON CPX
- K023120 — OXYCON MOBILE
- K011344 — INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400
- K001631 — CORTEX METAMAX
- K001174 — COSMED QUARK
- K001502 — AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO
- K992214 — OXYCON PRO
- K982499 — COSMO PLUS WITH NICO, MODEL 8200
- K982487 — CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO
- K970840 — INTELLIFLOW RESPIRATORY ANALYZER
- K963373 — COSMED K4
- K964360 — VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
- K954730 — BENCHMARK TRANSFER TEST
- K964939 — THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS
- K963380 — CO 2 SMO PLUS
- K960121 — AUTOLINK BODY PLETHYSMOGRAPH
- K953990 — TRANSFLOW TEST
- K960831 — VENTRAK RMMS 1550
- K952542 — ACKRAD ESOPHAGEAL BALLOON CATHETER SET
- K946077 — DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS
- K951157 — DX1-PORTABLE
- K941843 — MMS-2400
- K945213 — TEEN 100
- K942864 — LUNG DIFFUSION
- K935309 — LUNG DIFFUSION
- K921306 — ARGIS PULMONARY FUNCTION TESTING SYSTEM
- K915833 — SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART
- K915686 — MODEL 2900 METABOLIC MEASUREMENT CART
- K913681 — MULTISPIRO-BREEZE
- K905480 — SPIROSCOPE
- K900696 — BIORE CP-100 CARDIOPULMONARY MONITOR
- K895963 — MODIFIED STAR CALC
- K893845 — PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM
- K894839 — OS-1 OCCLUSION SYSTEM - 1
- K892670 — PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE)
- K892121 — SPIRO-LINK REAL TIME SPIROMETRY SYSTEM
- K881235 — Q-PLEX 1
- K883732 — ARGIS PULMONARY FUNCTION TESTING SYSTEM
- K875027 — STAR CALC
- K861418 — SPINNAKER
- K860844 — VISTA INTERFACE SYSSTEM
- K854626 — COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B
- K853443 — ALVEO-DIFFUSION TEST
- K855070 — SPIROMETER MODEL TS-200 SLZ 7541
- K852909 — MVP - 6000
- K851805 — LPA-3 PRINTER
- K843860 — OXYSCREEN
- K843848 — AW TEST
- K843852 — APTA-BRONCHOSCREEN
- K843849 — PNEUMOSCREEN
- K842760 — LUNG ANALYZER CM-310
- K840711 — PULMONARY FUNCTION SYS-3000
- K831777 — COLLINS DS
- K831778 — RS-RESIDUAL VOLUME SYSTEM
- K831779 — COLLINS EAGLE II
- K830954 — ACOH WELLNESS TESTER
- K822986 — PULMONARY FUNCTION LAB SYSTEM 1070
- K812001 — OSCILLAIRE
- K810751 — PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF
- K802920 — INSPIRON PULMONARY FUNCTION ANALYZER
- K810243 — SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME
- K810196 — SYSTEM 84 COMPUTERIZED LUNG VOL. SPIROM
- K803255 — AUTOMATED PULMONARY FUNCTION LABORATORY
- K802928 — SPIROMETRIC COMPUTER #SC-10
- K801497 — INFANT VENTILATORY MEASUREMENT SYSTEM
- K801918 — SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO
- K801919 — SYSTEM 88 COMPUTERIZED DIFFUSION ANALY
- K801920 — SYSTEM 80 COMPUTERIZED SPIROMETER
- K802116 — ANESTHESIA GAS MACHINE
- K801597 — PFT CALIBRATOR
- K801526 — SURVEYOR I, RESPIRATORY COMPUTER SYSTEM
- K801088 — F.R.C. APPARATUS
- K800547 — MEDISTOR III LUNG ANALYZER
- K791503 — VITALOGRAPH FUNCTION ANALYZER
- K790185 — MODEL V 4207 INTEGRATING PLUG-IN
- K780322 — ANALYZER, PULMONARY FUNCTION
- K780328 — PULMONARY FUNCTION TESTER, COMPUTERIZED
- K770532 — PC-30 PULMONARY COMPUTER
Data sourced from openFDA. This site is unofficial and independent of the FDA.