Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000

K-Number: K861277 · 1986-06-02

ApplicantCritichem, Inc.
Decision Date1986-06-02
Product CodeDRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Critichem, Inc.. It received FDA 510(k) clearance on 1986-06-02 under 510(k) number K861277. 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 CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000?

CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000 is a medical device that received FDA 510(k) clearance on 1986-06-02. The listed applicant is Critichem, Inc.. The 510(k) number is K861277.

When did CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000 receive FDA 510(k) clearance?

CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000 received FDA 510(k) clearance on 1986-06-02, under 510(k) number K861277.

Who is the listed applicant for CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000?

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

What is the FDA product code for CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000?

The FDA product code for CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000 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

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

View on FDA Database →

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

↑