PEDIATRIC VISION SCANNER
FDA 510(k) clearance DEN130051 · decided 2016-06-08
Clearance details
- K-number
- DEN130051
- Device name
- PEDIATRIC VISION SCANNER
- Applicant
- Rebiscan, Inc.
- Decision
- Unknown
- Date received
- 2013-12-13
- Decision date
- 2016-06-08
- Days to decision
- 908 days
- Clearance type
- Direct
- Product code
- PMW
- Device class
- 2
- Regulation number
- 886.1342
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Rebiscan
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.