CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM— 510(k) K872034

Name: FDA 510(k) clearance K872034
Creator: U.S. Food and Drug Administration
Published: 1987-09-18

Substantially Equivalent

Cardiomedics, Inc.

FDA 510(k) clearance K872034 for CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM, Substantially Equivalent on 1987-09-18. Applicant: Cardiomedics, Inc.. Device class: 2.

Clearance details

Applicant: Cardiomedics, Inc.
Product code: Code DRN
Device class: Class 2
Regulation: 21 CFR 870.5225
Advisory panel: Cardiovascular
Date received: 1987-05-27
Decision date: 1987-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

Download summary PDF View on FDA.gov ↗

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