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FDA 510(k)

VACU*MED GOLD EDITION OXYGEN GAS ANALYZER

K-Number: K973545 · 1998-05-26

ApplicantVacumed, Div. of Vacumetrics, Inc.
Decision Date1998-05-26
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VACU*MED GOLD EDITION OXYGEN GAS ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Vacumed, Div. of Vacumetrics, Inc.. It received FDA 510(k) clearance on 1998-05-26 under 510(k) number K973545. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACU*MED GOLD EDITION OXYGEN GAS ANALYZER?

VACU*MED GOLD EDITION OXYGEN GAS ANALYZER is a medical device that received FDA 510(k) clearance on 1998-05-26. The listed applicant is Vacumed, Div. of Vacumetrics, Inc.. The 510(k) number is K973545.

When did VACU*MED GOLD EDITION OXYGEN GAS ANALYZER receive FDA 510(k) clearance?

VACU*MED GOLD EDITION OXYGEN GAS ANALYZER received FDA 510(k) clearance on 1998-05-26, under 510(k) number K973545.

Who is the listed applicant for VACU*MED GOLD EDITION OXYGEN GAS ANALYZER?

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

What is the FDA product code for VACU*MED GOLD EDITION OXYGEN GAS ANALYZER?

The FDA product code for VACU*MED GOLD EDITION OXYGEN GAS ANALYZER is CCL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Vacumed, Div. of Vacumetrics, 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.

K973544VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER

Related Devices (Code: CCL)

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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, Inc.

Official Source

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

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