AXIOM ELECTROMYOGRAPH— 510(k) K912595

Substantially Equivalent

The Computerist, Inc.

FDA 510(k) clearance K912595 for AXIOM ELECTROMYOGRAPH, Substantially Equivalent on 1991-09-06. Applicant: The Computerist, Inc.. Device class: 2.

Clearance details

Applicant: The Computerist, Inc.
Product code: Code HCC
Device class: Class 2
Regulation: 21 CFR 882.5050
Advisory panel: Neurology
Date received: 1991-06-10
Decision date: 1991-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelmsford, MA, 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.