BTL ELITE— 510(k) K120093

Substantially Equivalent

BTL Industries, Inc.

FDA 510(k) clearance K120093 for BTL ELITE, Substantially Equivalent on 2012-10-05. Applicant: BTL Industries, Inc.. Device class: 2.

Clearance details

Applicant: BTL Industries, Inc.
Product code: Code IMJ
Device class: Class 2
Regulation: 21 CFR 890.5290
Advisory panel: Physical Medicine
Date received: 2012-01-12
Decision date: 2012-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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