FOCUS EMG DEVICE— 510(k) K102610

Substantially Equivalent

Teleemg, LLC USA

FDA 510(k) clearance K102610 for FOCUS EMG DEVICE, Substantially Equivalent on 2011-03-04. Applicant: Teleemg, LLC USA. Device class: 2.

Clearance details

Applicant: Teleemg, LLC USA
Product code: Code IKN
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 2010-09-10
Decision date: 2011-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

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