EPICARDIA 4000— 510(k) K900207

Substantially Equivalent

Medicomp, Inc.

FDA 510(k) clearance K900207 for EPICARDIA 4000, Substantially Equivalent on 1990-07-31. Applicant: Medicomp, Inc.. Device class: 2.

Clearance details

Applicant: Medicomp, Inc.
Product code: Code DST
Device class: Class 2
Regulation: 21 CFR 870.3260
Advisory panel: Cardiovascular
Date received: 1990-01-16
Decision date: 1990-07-31
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.