EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04— 510(k) K092913

Name: FDA 510(k) clearance K092913
Creator: U.S. Food and Drug Administration
Published: 2009-10-16

Substantially Equivalent

Ep Medsystems

FDA 510(k) clearance K092913 for EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04, Substantially Equivalent on 2009-10-16. Applicant: Ep Medsystems. Device class: 2.

Clearance details

Applicant: Ep Medsystems
Product code: Code JOQ
Device class: Class 2
Regulation: 21 CFR 870.1750
Advisory panel: Cardiovascular
Date received: 2009-09-22
Decision date: 2009-10-16
Decision: Substantially Equivalent
Clearance type: Special
Location: West Berlin, NJ, 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.