BTL-398— 510(k) K241516

Substantially Equivalent

BTL Industries, Inc.

FDA 510(k) clearance K241516 for BTL-398, Substantially Equivalent on 2025-02-10. Applicant: BTL Industries, Inc..

Clearance details

Applicant: BTL Industries, Inc.
Product code: Code KPI
Advisory panel: Gastroenterology, Urology
Date received: 2024-05-29
Decision date: 2025-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

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