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FDA 510(k)

SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES

K-Number: K053599 · 2006-04-19

ApplicantSpacelabs Medical, Inc.
Decision Date2006-04-19
Product CodeCBR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Medical, Inc.. It received FDA 510(k) clearance on 2006-04-19 under 510(k) number K053599. 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 MODULE 91518 AND ACCESSORIES?

SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2006-04-19. The listed applicant is Spacelabs Medical, Inc.. The 510(k) number is K053599.

When did SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES receive FDA 510(k) clearance?

SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES received FDA 510(k) clearance on 2006-04-19, under 510(k) number K053599.

Who is the listed applicant for SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES?

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

What is the FDA product code for SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES?

The FDA product code for SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES is CBR.

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Other records listing Spacelabs Medical, 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.

K120616SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390K112962SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)K102422SPACELABS MEDICAL PATIENT MONITORSK093501ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATIONK082045MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220K063490SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810

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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 HealthcareK954962SPACELABS MEDICAL MULTIGAS ANALYZERSpacelabs, 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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