MYOSYSTEM 1000 ELECTROMYOGRAPH— 510(k) K895635

Name: FDA 510(k) clearance K895635
Creator: U.S. Food and Drug Administration
Published: 1990-04-19

Substantially Equivalent

Noraxon USA, Inc.

FDA 510(k) clearance K895635 for MYOSYSTEM 1000 ELECTROMYOGRAPH, Substantially Equivalent on 1990-04-19. Applicant: Noraxon USA, Inc.. Device class: 2.

Clearance details

Applicant: Noraxon USA, Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1989-09-19
Decision date: 1990-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

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