Electrohydraulic Lithotriptor (TCS-B3-II)— 510(k) K242888

Substantially Equivalent

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

FDA 510(k) clearance K242888 for Electrohydraulic Lithotriptor (TCS-B3-II), Substantially Equivalent on 2025-03-21. Applicant: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd..

Clearance details

Applicant: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Product code: Code FFK
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-23
Decision date: 2025-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

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