Atlas FDA

CBQ

22 FDA 510(k) clearances · Product code

178 daysmedian time to decision
374 days90th percentile
22clearances measured

FDA profile

Official device name
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1500
Medical specialty
Anesthesiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1999: 4 · 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B (K040917)Philips Medizin Systeme Boeblingen GmbH2004-04-29
MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 (K994188)Agilent Technologies, GmbH2000-05-19
OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR (K962648)Ohmeda Medical1997-01-17
OHMEDA MODEL 5330 ANESTHETIC MONITOR (K931439)Ohmeda Medical1993-10-19
DATASCOPE MULTINEX II (K926451)Datascope Corp.1993-08-25
AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (K923433)Instrumentarium Corp.1993-07-22
CAPNOMAC ULTIMA ANESTHESIA MONITOR (K923276)Datex Division Instrumentarium Corp.1993-07-21
AS/3 COP MODULE (K922876)Datex Division Instrumentarium Corp.1993-07-21
DATASCOPE MULTINEX ID PLUS (K930303)Datascope Corp.1993-06-16
ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED (K914295)Bruel & Kjaer1992-04-10
NGM FRAME (K911644)Datex Division Instrumentarium Corp.1992-03-04
NGM GAS MODULE (K911647)Datex Division Instrumentarium Corp.1991-09-19
CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR (K903104)Datex Division Instrumentarium Corp.1991-01-23
RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR (K902021)Albion Instruments1990-10-09
ANESTHETIC AGENT MONITOR (K892854)Criticare Systems, Inc.1989-10-13
BIOCHEM 8100 ANESTHETIC AGENT MONITOR (K892646)Biochem International, Inc.1989-08-31
OHMEDA 5330 AGENT MONITOR (K890606)Ohmeda Medical1989-04-20
ICOR AGENT MONITOR (K883532)Icor AB1988-11-04
PERMA PURE NAFION TUBE DRYER-MODEL ME (K881264)Perma Pure Products, Inc.1988-10-25
PB GRAPHICS PRINTER AND PB VIDEO DISPLAY (K863248)Datex Division Instrumentarium Corp.1986-09-03
OHMEDA 5300 ANESTHETIC AGENT MONITOR (K861397)Ohmeda Medical1986-05-29
PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT (K861474)Datex Division Instrumentarium Corp.1986-05-02

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