SOPRO 184 CAMERA
FDA 510(k) clearance K082796 · decided 2009-04-01
Clearance details
- K-number
- K082796
- Device name
- SOPRO 184 CAMERA
- Applicant
- Sopro
- Decision
- Substantially Equivalent
- Date received
- 2008-09-23
- Decision date
- 2009-04-01
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- GCJ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mt. Laurel, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.