CERSR ELECTROMYOGRAPHY SYSTEM— 510(k) K110048

Name: FDA 510(k) clearance K110048
Creator: U.S. Food and Drug Administration
Published: 2011-01-26

Substantially Equivalent

Spinematrix, Inc.

FDA 510(k) clearance K110048 for CERSR ELECTROMYOGRAPHY SYSTEM, Substantially Equivalent on 2011-01-26. Applicant: Spinematrix, Inc.. Device class: 2.

Clearance details

Applicant: Spinematrix, Inc.
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 2011-01-06
Decision date: 2011-01-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Philedelphia, PA, 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.