ABCOM 1 CARDIAC OUTPUT MONITOR— 510(k) K870857

Name: FDA 510(k) clearance K870857
Creator: U.S. Food and Drug Administration
Published: 1987-11-16

Substantially Equivalent

Applied Biometrics, Inc.

FDA 510(k) clearance K870857 for ABCOM 1 CARDIAC OUTPUT MONITOR, Substantially Equivalent on 1987-11-16. Applicant: Applied Biometrics, Inc.. Device class: 2.

Clearance details

Applicant: Applied Biometrics, Inc.
Product code: Code JOP
Device class: Class 2
Regulation: 21 CFR 870.2880
Advisory panel: Cardiovascular
Date received: 1987-03-03
Decision date: 1987-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

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