Atlas FDA

CBS

17 FDA 510(k) clearances · Product code

91 daysmedian time to decision
244 days90th percentile
17clearances measured

FDA profile

Official device name
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1620
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1995: 1 · 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
GAS MODULE II, MODEL 0998-00-0143 (K974903)Datascope Corp.1998-03-13
VITALMAX 4100 (K953795)Pace Tech, Inc.1996-07-01
AS/3 COMPACT AIRWAY MODULE M-CAIOV (K960490)Datex Medical Instrumentation, Inc.1996-05-03
RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) (K951366)Riken Keiki Co., Ltd.1995-08-02
RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR (K950101)Marquette Electronics, Inc.1995-03-21
AS/3 AIRWAY MODULE (K943458)Datex Division Instrumentarium Corp.1995-02-14
POET IQ WITH FIVE AGENT CAPABILITY (K942737)Criticare Systems, Inc.1995-02-09
8100 ANESTHETIC AGENT MONITOR (K932389)Biochem International, Inc.1993-12-03
CAPNOMAC ULTIMA ANESTHESIA MONITOR (K905754)Datex Division Instrumentarium Corp.1991-06-17
NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR (K896629)Nellcor, Inc.1990-02-12
HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A (K896216)Hewlett-Packard Co.1990-01-16
ANESTHETIC GAS MONITOR (K890446)Bruel & Kjaer Instruments, Inc.1989-08-11
SPECTRAMED RESPIRATORY GAS ANALYZER (K873194)Draeger Medical, Inc.1987-10-30
TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR (K863801)Traverse Medical Monitors1987-01-12
NORMAC ANESTHETIC AGENT MONITOR (K832113)Datex Division Instrumentarium Corp.1983-09-12
SARA (K810585)Allied Healthcare Products, Inc.1981-03-24
ENGSTROM EMMA ANESTHETIC GAS MONITOR (K802614)Lkb Instruments, Inc.1981-01-07

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Every clearance here is in the API, with alerts when new ones post.