CARDIAC OUTPUT COMPUTER, MODEL COM-3— 510(k) K896930

Name: FDA 510(k) clearance K896930
Creator: U.S. Food and Drug Administration
Published: 1990-07-03

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K896930 for CARDIAC OUTPUT COMPUTER, MODEL COM-3, Substantially Equivalent on 1990-07-03. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1989-12-11
Decision date: 1990-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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