VS3-IR system
FDA 510(k) clearance K152204 · decided 2015-10-28
Clearance details
- K-number
- K152204
- Device name
- VS3-IR system
- Applicant
- Visionsense, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-06
- Decision date
- 2015-10-28
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- OWN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Petach Tikva, Hamerkaz, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.