510(k) DEN130051
DEN130051 is an FDA 510(k) premarket notification submitted by Rebiscan, Inc. for the device "PEDIATRIC VISION SCANNER". The FDA issued a decision of De Novo Granted on June 8, 2016. The device falls under product code PMW (Strabismus Detection Device), a Class II device regulated under 21 CFR 886.1342.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 8, 2016
- Date Received
- December 13, 2013
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strabismus Detection Device
- Device Class
- Class II
- Regulation Number
- 886.1342
- Review Panel
- OP
- Submission Type
For the automated detection of misalignment of the visual axes for prescription use only.