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FDA 510(k)

SPACELABS MEDICAL MULTIGAS ANALYZER

K-Number: K954962 · 1996-05-31

ApplicantSpacelabs, Inc.
Decision Date1996-05-31
Product CodeCBR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPACELABS MEDICAL MULTIGAS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1996-05-31 under 510(k) number K954962. The device is classified under product code CBR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELABS MEDICAL MULTIGAS ANALYZER?

SPACELABS MEDICAL MULTIGAS ANALYZER is a medical device that received FDA 510(k) clearance on 1996-05-31. The listed applicant is Spacelabs, Inc.. The 510(k) number is K954962.

When did SPACELABS MEDICAL MULTIGAS ANALYZER receive FDA 510(k) clearance?

SPACELABS MEDICAL MULTIGAS ANALYZER received FDA 510(k) clearance on 1996-05-31, under 510(k) number K954962.

Who is the listed applicant for SPACELABS MEDICAL MULTIGAS ANALYZER?

The FDA 510(k) record lists Spacelabs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPACELABS MEDICAL MULTIGAS ANALYZER?

The FDA product code for SPACELABS MEDICAL MULTIGAS ANALYZER is CBR.

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Other records listing Spacelabs, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K951605SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEMK950779HEART RATE VARIABILITY SOFTWARE OPTIONK941165COMET CAPNOGRAPH MODULEK923788SPACE LABS MODEL 90560K912742ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBEK913038SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION

View all 46 devices →

Related Devices (Code: CBR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112173SPEACELABS MULTIGAS MODULESpacelabs HealthcareK053599SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIESSpacelabs Medical, Inc.K904843OSCAR(TM) II CAPNOMETER & PULSE OXIMETERDalton Instrument Corp.K853360N20 TESTErich Jaeger, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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