CBQ · Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Anesthesiology · 21 CFR 868.1500 · Class 2
Overview
| Product Code | CBQ |
|---|---|
| Device Name | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) |
| Regulation | 21 CFR 868.1500 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 22)
Showing 20 most recent of 22 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K040917 | PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B | Philips Medizin Systeme Boeblingen GmbH | Apr 29, 2004 | SESE |
| K994188 | MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 | Agilent Technologies, GmbH | May 19, 2000 | SESE |
| K962648 | OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR | Ohmeda Medical | Jan 17, 1997 | SESE |
| K931439 | OHMEDA MODEL 5330 ANESTHETIC MONITOR | Ohmeda Medical | Oct 19, 1993 | SESE |
| K926451 | DATASCOPE MULTINEX II | Datascope Corp. | Aug 25, 1993 | SESE |
| K923433 | AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE | Instrumentarium Corp. | Jul 22, 1993 | SESE |
| K923276 | CAPNOMAC ULTIMA ANESTHESIA MONITOR | Datex Division Instrumentarium Corp. | Jul 21, 1993 | SESE |
| K922876 | AS/3 COP MODULE | Datex Division Instrumentarium Corp. | Jul 21, 1993 | SESE |
| K930303 | DATASCOPE MULTINEX ID PLUS | Datascope Corp. | Jun 16, 1993 | SESE |
| K914295 | ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED | Bruel & Kjaer | Apr 10, 1992 | SESE |
| K911644 | NGM FRAME | Datex Division Instrumentarium Corp. | Mar 4, 1992 | SESE |
| K911647 | NGM GAS MODULE | Datex Division Instrumentarium Corp. | Sep 19, 1991 | SESE |
| K903104 | CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR | Datex Division Instrumentarium Corp. | Jan 23, 1991 | SESE |
| K902021 | RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR | Albion Instruments | Oct 9, 1990 | SESE |
| K892854 | ANESTHETIC AGENT MONITOR | Criticare Systems, Inc. | Oct 13, 1989 | SESE |
| K892646 | BIOCHEM 8100 ANESTHETIC AGENT MONITOR | Biochem International, Inc. | Aug 31, 1989 | SESE |
| K890606 | OHMEDA 5330 AGENT MONITOR | Ohmeda Medical | Apr 20, 1989 | SESE |
| K883532 | ICOR AGENT MONITOR | Icor AB | Nov 4, 1988 | SESE |
| K881264 | PERMA PURE NAFION TUBE DRYER-MODEL ME | Perma Pure Products, Inc. | Oct 25, 1988 | SESE |
| K863248 | PB GRAPHICS PRINTER AND PB VIDEO DISPLAY | Datex Division Instrumentarium Corp. | Sep 3, 1986 | SESE |
Top Applicants
- Datex Division Instrumentarium Corp. — 7 clearances
- Ohmeda Medical — 4 clearances
- Datascope Corp. — 2 clearances
- Agilent Technologies, GmbH — 1 clearance
- Albion Instruments — 1 clearance
