VIKY UP
FDA 510(k) clearance K122820 · decided 2013-06-18
Clearance details
- K-number
- K122820
- Device name
- VIKY UP
- Applicant
- Endocontrol
- Decision
- Substantially Equivalent
- Date received
- 2012-09-14
- Decision date
- 2013-06-18
- Days to decision
- 277 days
- Clearance type
- Traditional
- Product code
- LKF
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- La Tronche, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.