EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR— 510(k) K935590

Name: FDA 510(k) clearance K935590
Creator: U.S. Food and Drug Administration
Published: 1994-05-05

Substantially Equivalent

Ep Medical, Inc.

FDA 510(k) clearance K935590 for EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR, Substantially Equivalent on 1994-05-05. Applicant: Ep Medical, Inc.. Device class: 2.

Clearance details

Applicant: Ep Medical, Inc.
Product code: Code JOQ
Device class: Class 2
Regulation: 21 CFR 870.1750
Advisory panel: Cardiovascular
Date received: 1993-11-18
Decision date: 1994-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Budd Lake, NJ, US

Download summary PDF View on FDA.gov ↗

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