Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1620](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1620) → CBS — Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

# CBS · Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

_Anesthesiology · 21 CFR 868.1620 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS

## Overview

- **Product Code:** CBS
- **Device Name:** Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- **Regulation:** [21 CFR 868.1620](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1620)
- **Device Class:** 2
- **Review Panel:** [Anesthesiology](/submissions/AN)
- **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](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K974903.md) | GAS MODULE II, MODEL 0998-00-0143 | Datascope Corp. | Mar 13, 1998 | SESE |
| [K953795](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K953795.md) | VITALMAX 4100 | Pace Tech, Inc. | Jul 1, 1996 | SESE |
| [K960490](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K960490.md) | AS/3 COMPACT AIRWAY MODULE M-CAIOV | Datex Medical Instrumentation, Inc. | May 3, 1996 | SESE |
| [K951366](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K951366.md) | RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18) | Riken Keiki Co., Ltd. | Aug 2, 1995 | SESE |
| [K950101](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K950101.md) | RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR | Marquette Electronics, Inc. | Mar 21, 1995 | SESE |
| [K943458](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K943458.md) | AS/3 AIRWAY MODULE | Datex Division Instrumentarium Corp. | Feb 14, 1995 | SESE |
| [K942737](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K942737.md) | POET IQ WITH FIVE  AGENT CAPABILITY | Criticare Systems, Inc. | Feb 9, 1995 | SESE |
| [K932389](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K932389.md) | 8100 ANESTHETIC AGENT MONITOR | Biochem International, Inc. | Dec 3, 1993 | SESE |
| [K905754](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K905754.md) | CAPNOMAC ULTIMA ANESTHESIA MONITOR | Datex Division Instrumentarium Corp. | Jun 17, 1991 | SESE |
| [K896629](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K896629.md) | NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR | Nellcor, Inc. | Feb 12, 1990 | SESE |
| [K896216](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K896216.md) | HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A | Hewlett-Packard Co. | Jan 16, 1990 | SESE |
| [K890446](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K890446.md) | ANESTHETIC GAS MONITOR | Bruel & Kjaer Instruments, Inc. | Aug 11, 1989 | SESE |
| [K873194](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K873194.md) | SPECTRAMED RESPIRATORY GAS ANALYZER | Draeger Medical, Inc. | Oct 30, 1987 | SESE |
| [K863801](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K863801.md) | TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR | Traverse Medical Monitors | Jan 12, 1987 | SESE |
| [K832113](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K832113.md) | NORMAC ANESTHETIC AGENT MONITOR | Datex Division Instrumentarium Corp. | Sep 12, 1983 | SESE |
| [K810585](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K810585.md) | SARA | Allied Healthcare Products, Inc. | Mar 24, 1981 | SESE |
| [K802614](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS/K802614.md) | 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

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/CBS)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com