CARDICAD(TM)— 510(k) K881392

Name: FDA 510(k) clearance K881392
Creator: U.S. Food and Drug Administration
Published: 1988-05-31

Substantially Equivalent

Medical/Surgical Specialties, Ltd.

FDA 510(k) clearance K881392 for CARDICAD(TM), Substantially Equivalent on 1988-05-31. Applicant: Medical/Surgical Specialties, Ltd.. Device class: 1.

Clearance details

Applicant: Medical/Surgical Specialties, Ltd.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1988-04-04
Decision date: 1988-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

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