EHL Probe (3 models)— 510(k) K243032
Substantially EquivalentGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
FDA 510(k) clearance K243032 for EHL Probe (3 models), Substantially Equivalent on 2025-03-21. Applicant: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)
- 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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