510(k) DEN130051
- Device
- PEDIATRIC VISION SCANNER
- Applicant
- Rebiscan, Inc.
- 510(k) number
- DEN130051
- Product code
- PMW
- Decision
- Unknown (DENG)
- Decision date
- 2016-06-08
- Date received
- 2013-12-13
- Regulation
- 886.1342
- Classification name
- Strabismus Detection Device
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- JUSTIN G SHAKA
- Address
- 30 Mount Auburn St., Suite B Cambridge MA US 02138 02138
FDA Registration Numbers#
- 3014522421
- 3012983142
Source Documents#
510(k) summary PDF not indicated by FDA