GERARD MEDICAL ELECTRODE TESTER— 510(k) K813358

Name: FDA 510(k) clearance K813358
Creator: U.S. Food and Drug Administration
Published: 1981-12-29

Substantially Equivalent

Gerard Medical Enterprises, Inc.

FDA 510(k) clearance K813358 for GERARD MEDICAL ELECTRODE TESTER, Substantially Equivalent on 1981-12-29. Applicant: Gerard Medical Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Gerard Medical Enterprises, Inc.
Product code: Code KRC
Device class: Class 2
Regulation: 21 CFR 870.2370
Advisory panel: Cardiovascular
Date received: 1981-11-30
Decision date: 1981-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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