CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000— 510(k) K861277

Name: FDA 510(k) clearance K861277
Creator: U.S. Food and Drug Administration
Published: 1986-06-02

Substantially Equivalent

Critichem, Inc.

FDA 510(k) clearance K861277 for CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-1000, Substantially Equivalent on 1986-06-02. Applicant: Critichem, Inc.. Device class: 2.

Clearance details

Applicant: Critichem, Inc.
Product code: Code DRY
Device class: Class 2
Regulation: 21 CFR 870.4330
Advisory panel: Cardiovascular
Date received: 1986-04-07
Decision date: 1986-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Little Falls, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.