PMW · Class II · 21 CFR 886.1342

FDA Product Code PMW: Strabismus Detection Device

For The Automated Detection Of Misalignment Of The Visual Axes For Prescription Use Only.

Leading manufacturers include Rebiscan, Inc..

1
Total
0
Cleared
908d
Avg days
2016
Since

FDA 510(k) Cleared Strabismus Detection Device Devices (Product Code PMW)

1 devices
1–1 of 1
Not Cleared Jun 08, 2016
PEDIATRIC VISION SCANNER
DEN130051
Rebiscan, Inc.
Ophthalmic · 908d

About Product Code PMW - Regulatory Context