Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
FDA 510(k) clearance K200617 · decided 2020-06-23
Clearance details
- K-number
- K200617
- Device name
- Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525
- Applicant
- Richard Wolf Medical Instruments Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-03-09
- Decision date
- 2020-06-23
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- FET
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Vernon Hills, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.