PMW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Strabismus Detection Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1342
- Medical specialty
- Ophthalmic
- FDA definition
- For the automated detection of misalignment of the visual axes for prescription use only.
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| Record | Firm | Date |
|---|---|---|
| PEDIATRIC VISION SCANNER (DEN130051) | Rebiscan, Inc. | 2016-06-08 |
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