BTL-899M— 510(k) K232937

Substantially Equivalent

BTL Industries, Inc.

FDA 510(k) clearance K232937 for BTL-899M, Substantially Equivalent on 2023-12-26. 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: 2023-09-20
Decision date: 2023-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

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