MODEL ME 300 MUSCLE TESTER— 510(k) K943535

Name: FDA 510(k) clearance K943535
Creator: U.S. Food and Drug Administration
Published: 1997-06-25

Substantially Equivalent

Regulatory Strategies, Inc.

FDA 510(k) clearance K943535 for MODEL ME 300 MUSCLE TESTER, Substantially Equivalent on 1997-06-25. Applicant: Regulatory Strategies, Inc.. Device class: 2.

Clearance details

Applicant: Regulatory Strategies, Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1994-07-21
Decision date: 1997-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eagan, MN, US

Download summary PDF View on FDA.gov ↗

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