Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
FDA 510(k) clearance K221781 · decided 2023-02-02
Clearance details
- K-number
- K221781
- Device name
- Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH
- Applicant
- Guangdong Optomedic Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-21
- Decision date
- 2023-02-02
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Foshan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.