Electrohydraulic Lithotriptor (TCS-B3-II)— 510(k) K242888
Substantially EquivalentGuangzhou 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.. Device class: 2.
Clearance details
- Applicant
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
- Product code
- Code FFK
- Device class
- Class 2
- Regulation
- 21 CFR 876.4480
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code FFK
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