CBS · Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Anesthesiology · 21 CFR 868.1620 · Class 2
Overview
| Product Code | CBS |
|---|---|
| Device Name | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) |
| Regulation | 21 CFR 868.1620 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A halothane gas analyzer is a device intended to measure the concentration of halothane anesthetic in a gas mixture. The device may use techniques such as mass spectrometry or absorption of infrared or ultraviolet radiation.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974903 | GAS MODULE II, MODEL 0998-00-0143 | Datascope Corp. | Mar 13, 1998 | SESE |
| K953795 | VITALMAX 4100 | Pace Tech, Inc. | Jul 1, 1996 | SESE |
| K960490 | AS/3 COMPACT AIRWAY MODULE M-CAIOV | Datex Medical Instrumentation, Inc. | May 3, 1996 | SESE |
| K951366 | RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) | Riken Keiki Co., Ltd. | Aug 2, 1995 | SESE |
| K950101 | RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR | Marquette Electronics, Inc. | Mar 21, 1995 | SESE |
| K943458 | AS/3 AIRWAY MODULE | Datex Division Instrumentarium Corp. | Feb 14, 1995 | SESE |
| K942737 | POET IQ WITH FIVE AGENT CAPABILITY | Criticare Systems, Inc. | Feb 9, 1995 | SESE |
| K932389 | 8100 ANESTHETIC AGENT MONITOR | Biochem International, Inc. | Dec 3, 1993 | SESE |
| K905754 | CAPNOMAC ULTIMA ANESTHESIA MONITOR | Datex Division Instrumentarium Corp. | Jun 17, 1991 | SESE |
| K896629 | NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR | Nellcor, Inc. | Feb 12, 1990 | SESE |
| K896216 | HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A | Hewlett-Packard Co. | Jan 16, 1990 | SESE |
| K890446 | ANESTHETIC GAS MONITOR | Bruel & Kjaer Instruments, Inc. | Aug 11, 1989 | SESE |
| K873194 | SPECTRAMED RESPIRATORY GAS ANALYZER | Draeger Medical, Inc. | Oct 30, 1987 | SESE |
| K863801 | TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR | Traverse Medical Monitors | Jan 12, 1987 | SESE |
| K832113 | NORMAC ANESTHETIC AGENT MONITOR | Datex Division Instrumentarium Corp. | Sep 12, 1983 | SESE |
| K810585 | SARA | Allied Healthcare Products, Inc. | Mar 24, 1981 | SESE |
| K802614 | ENGSTROM EMMA ANESTHETIC GAS MONITOR | Lkb Instruments, Inc. | Jan 7, 1981 | SESE |
Top Applicants
- Datex Division Instrumentarium Corp. — 3 clearances
- Traverse Medical Monitors — 1 clearance
- Riken Keiki Co., Ltd. — 1 clearance
- Pace Tech, Inc. — 1 clearance
- Nellcor, Inc. — 1 clearance
