DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,— 510(k) K091410

Name: FDA 510(k) clearance K091410
Creator: U.S. Food and Drug Administration
Published: 2009-08-11

Substantially Equivalent

Spes Medica Srl

FDA 510(k) clearance K091410 for DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,, Substantially Equivalent on 2009-08-11. Applicant: Spes Medica Srl. Device class: 2.

Clearance details

Applicant: Spes Medica Srl
Product code: Code IKT
Device class: Class 2
Regulation: 21 CFR 890.1385
Advisory panel: Physical Medicine
Date received: 2009-05-13
Decision date: 2009-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Battipaglia, IT

Download summary PDF View on FDA.gov ↗

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