3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)
FDA 510(k) clearance K233892 · decided 2024-06-13
Clearance details
- K-number
- K233892
- Device name
- 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)
- Applicant
- Zhuhai Dipu Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-12-08
- Decision date
- 2024-06-13
- Days to decision
- 188 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Zhuhai, Jinwan District, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.