CARDIOPAL MODEL NUMBER PM20— 510(k) K981119

Substantially Equivalent

Medicomp, Inc.

FDA 510(k) clearance K981119 for CARDIOPAL MODEL NUMBER PM20, Substantially Equivalent on 1998-10-14. Applicant: Medicomp, Inc.. Device class: 2.

Clearance details

Applicant: Medicomp, Inc.
Product code: Code DXH
Device class: Class 2
Regulation: 21 CFR 870.2920
Advisory panel: Cardiovascular
Date received: 1998-03-27
Decision date: 1998-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

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