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FDA 510(k)

CARDIOMET 4000 GAS MONITORING SYSTEMS

K-Number: K862069 · 1986-07-18

ApplicantBiomedical Sensors, Inc.
Decision Date1986-07-18
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOMET 4000 GAS MONITORING SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Sensors, Inc.. It received FDA 510(k) clearance on 1986-07-18 under 510(k) number K862069. The device is classified under product code DRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOMET 4000 GAS MONITORING SYSTEMS?

CARDIOMET 4000 GAS MONITORING SYSTEMS is a medical device that received FDA 510(k) clearance on 1986-07-18. The listed applicant is Biomedical Sensors, Inc.. The 510(k) number is K862069.

When did CARDIOMET 4000 GAS MONITORING SYSTEMS receive FDA 510(k) clearance?

CARDIOMET 4000 GAS MONITORING SYSTEMS received FDA 510(k) clearance on 1986-07-18, under 510(k) number K862069.

Who is the listed applicant for CARDIOMET 4000 GAS MONITORING SYSTEMS?

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

What is the FDA product code for CARDIOMET 4000 GAS MONITORING SYSTEMS?

The FDA product code for CARDIOMET 4000 GAS MONITORING SYSTEMS is DRY.

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 Biomedical Sensors, 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.

K953893PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM

Related Devices (Code: DRY)

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.

K234065CDI OneView Monitoring SystemTerumo Cardiovascular Systems CorporationK202154B-CaptaLivanova Deutschland, GmbHK202557Quantum Workstation 12 EliteSpectrum Medical , Ltd.K182110CDI Blood Parameter Monitoring System 550Terumo Cardiovascular Systems CorporationK181923Quantum Workstation 12.1Spectrum Medical , Ltd.K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical , Ltd.

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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