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FDA 510(k)

VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER

K-Number: K973544 · 1998-05-26

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

Device Summary

VACU*MED, GOLD EDITION CARBON DIOXIDE 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 K973544. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER?

VACU*MED, GOLD EDITION CARBON DIOXIDE 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 K973544.

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

VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER received FDA 510(k) clearance on 1998-05-26, under 510(k) number K973544.

Who is the listed applicant for VACU*MED, GOLD EDITION CARBON DIOXIDE 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 CARBON DIOXIDE GAS ANALYZER?

The FDA product code for VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER is CCK.

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.

K973545VACU*MED GOLD EDITION OXYGEN GAS ANALYZER

Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, 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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