Product code FLS— Anesthesiology
RESPIRATION MONITOR
- Classification name
- Monitor, Apnea, Facility Use
- Device class
- Class 2
- Regulation
- 21 CFR 868.2377
- Advisory panel
- Anesthesiology
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code FLS
FDA has cleared devices under product code FLS between 1976 and 2002, filed by 16 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
- 2002
- 2000
- 1996
- 1989
- 1984
- 1983
- 1982
- 1981
- 1980
- 1978
- 1976
Top applicants under product code FLS
Recent clearances under product code FLS
- K011597 — SMARTMONITOR 2, MODEL 4000
- K991087 — HANNAH WIRELESS VITAL SIGNS MONITOR
- K962865 — REMBRANDT SYSTEM
- K951246 — PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS
- K894973 — RESPITRACE PLUS
- K832999 — RESPIRATION MONITOR
- K830778 — MONITORING KIT AMK-1
- K822077 — RESPIRATION MONITOR TYPE MR-10
- K821721 — CLINICAL DATA APNEA DETECTOR
- K820943 — SYSTEM I INFANT MONITORING SYS
- K810153 — VENTILATORY EFFORT MONITOR
- K802710 — INFANT APNEA MONITOR
- K800164 — 413A NEONATAL MONITOR
- K781216 — INFUSION CONTROLLER, PARENTERAL
- K760104 — RESPIRATION MONITOR
- K760635 — MEDI-DYNE APNEA MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.