Product Code: CBS FDA class 2 21 CFR 868.1620

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

Anesthesiology

The Gaseous-Phase Halothane Anesthetic Concentration Analyzer is an anesthesiology device that measures and monitors the concentration of halothane, a volatile anesthetic agent, in the gas phase of the breathing circuit to allow accurate management of anesthetic depth during procedures. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CBS, regulated under 21 CFR 868.1620, within the Anesthesiology medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: CBS
Device Class: FDA class 2
Regulation Number: 868.1620
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 17 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K974903	GAS MODULE II, MODEL 0998-00-0143	Mar 13, 1998	Substantially Equivalent	Datascope Corp.
K953795	VITALMAX 4100	Jul 01, 1996	Substantially Equivalent	Pace Tech, Inc.
K960490	AS/3 COMPACT AIRWAY MODULE M-CAIOV	May 03, 1996	Substantially Equivalent	Datex Medical Instrumentation, Inc.
K951366	RIKEN GAS INDICATOR (3 MODELS, 1806H, 1802D, IF-18)	Aug 02, 1995	Substantially Equivalent	Riken Keiki Co., Ltd.
K950101	RAMS (RANDOM ACCESS MASS SPECTROMETER) M-200 RESPIRATORY GAS MONITOR	Mar 21, 1995	Substantially Equivalent	Marquette Electronics, Inc.
K943458	AS/3 AIRWAY MODULE	Feb 14, 1995	Substantially Equivalent	Datex Division Instrumentarium Corp.
K942737	POET IQ WITH FIVE AGENT CAPABILITY	Feb 09, 1995	Substantially Equivalent	Criticare Systems, Inc.
K932389	8100 ANESTHETIC AGENT MONITOR	Dec 03, 1993	Substantially Equivalent	Biochem International, Inc.
K905754	CAPNOMAC ULTIMA ANESTHESIA MONITOR	Jun 17, 1991	Substantially Equivalent	Datex Division Instrumentarium Corp.
K896629	NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR	Feb 12, 1990	Substantially Equivalent	Nellcor, Inc.
K896216	HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A	Jan 16, 1990	Substantially Equivalent	Hewlett-Packard Co.
K890446	ANESTHETIC GAS MONITOR	Aug 11, 1989	Substantially Equivalent	Bruel & Kjaer Instruments, Inc.
K873194	SPECTRAMED RESPIRATORY GAS ANALYZER	Oct 30, 1987	Substantially Equivalent	Draeger Medical, Inc.
K863801	TMM MODEL 3000 ANESTHESIA CIRCUIT EVALUATOR	Jan 12, 1987	Substantially Equivalent	Traverse Medical Monitors
K832113	NORMAC ANESTHETIC AGENT MONITOR	Sep 12, 1983	Substantially Equivalent	Datex Division Instrumentarium Corp.
K810585	SARA	Mar 24, 1981	Substantially Equivalent	Allied Healthcare Products, Inc.
K802614	ENGSTROM EMMA ANESTHETIC GAS MONITOR	Jan 07, 1981	Substantially Equivalent	Lkb Instruments, Inc.