HPM-6000— 510(k) K160992

Substantially Equivalent

BTL Industries, Inc.

FDA 510(k) clearance K160992 for HPM-6000, Substantially Equivalent on 2016-10-21. Applicant: BTL Industries, Inc.. Device class: 2.

Clearance details

Applicant: BTL Industries, Inc.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2016-04-08
Decision date: 2016-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Framingham, MA, US

Download summary PDF View on FDA.gov ↗

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