Product code CBS— Anesthesiology
8100 ANESTHETIC AGENT MONITOR
- Classification name
- Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- Device class
- Class 2
- Regulation
- 21 CFR 868.1620
- Advisory panel
- Anesthesiology
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code CBS
FDA has cleared devices under product code CBS between 1981 and 1998, filed by 15 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
- 1998
- 1996
- 1995
- 1993
- 1991
- 1990
- 1989
- 1987
- 1983
- 1981
Top applicants under product code CBS
Recent clearances under product code CBS
- K974903 — GAS MODULE II, MODEL 0998-00-0143
- K953795 — VITALMAX 4100
- K960490 — AS/3 COMPACT AIRWAY MODULE M-CAIOV
- K951366 — RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)
- K950101 — RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR
- K943458 — AS/3 AIRWAY MODULE
- K942737 — POET IQ WITH FIVE AGENT CAPABILITY
- K932389 — 8100 ANESTHETIC AGENT MONITOR
- K905754 — CAPNOMAC ULTIMA ANESTHESIA MONITOR
- K896629 — NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR
- K896216 — HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A
- K890446 — ANESTHETIC GAS MONITOR
- K873194 — SPECTRAMED RESPIRATORY GAS ANALYZER
- K863801 — TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR
- K832113 — NORMAC ANESTHETIC AGENT MONITOR
- K810585 — SARA
- K802614 — ENGSTROM EMMA ANESTHETIC GAS MONITOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.