ENDOSCOPY VIDEO CAMERA SYSTEM
FDA 510(k) clearance K081585 · decided 2008-06-20
Clearance details
- K-number
- K081585
- Device name
- ENDOSCOPY VIDEO CAMERA SYSTEM
- Applicant
- Vision Systems Group, A Division of Viking Systems
- Decision
- Substantially Equivalent
- Date received
- 2008-06-05
- Decision date
- 2008-06-20
- Days to decision
- 15 days
- Clearance type
- Special
- Product code
- FET
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- South Grafton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.