CERSR ELECTROMYOGRAPHY SYSTEM— 510(k) K990766

Name: FDA 510(k) clearance K990766
Creator: U.S. Food and Drug Administration
Published: 1999-08-27

Substantially Equivalent

Paraspinal Diagnostic Corp.

FDA 510(k) clearance K990766 for CERSR ELECTROMYOGRAPHY SYSTEM, Substantially Equivalent on 1999-08-27. Applicant: Paraspinal Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: Paraspinal Diagnostic Corp.
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 1999-03-08
Decision date: 1999-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, 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.