GS-128 GRADIENT COMPRESSION SYSTEM— 510(k) K050584

Name: FDA 510(k) clearance K050584
Creator: U.S. Food and Drug Administration
Published: 2005-03-22

Substantially Equivalent

Medmark Technologies, LLC

FDA 510(k) clearance K050584 for GS-128 GRADIENT COMPRESSION SYSTEM, Substantially Equivalent on 2005-03-22. Applicant: Medmark Technologies, LLC. Device class: 2.

Clearance details

Applicant: Medmark Technologies, LLC
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2005-03-07
Decision date: 2005-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Perkasie, PA, US

Download summary PDF View on FDA.gov ↗

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