ELITE ELECTROMED L.I.T.E. 4/1— 510(k) K053507

Name: FDA 510(k) clearance K053507
Creator: U.S. Food and Drug Administration
Published: 2006-03-15

Substantially Equivalent

Elite Electromedical

FDA 510(k) clearance K053507 for ELITE ELECTROMED L.I.T.E. 4/1, Substantially Equivalent on 2006-03-15. Applicant: Elite Electromedical. Device class: 2.

Clearance details

Applicant: Elite Electromedical
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2005-12-16
Decision date: 2006-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Osage Beach, MO, US

Download summary PDF View on FDA.gov ↗

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