PMW — Strabismus Detection Device Class II
Classification Details
- Product Code
- PMW
- Device Class
- Class II
- Regulation Number
- 886.1342
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
For the automated detection of misalignment of the visual axes for prescription use only.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN130051 | rebiscan | PEDIATRIC VISION SCANNER | June 8, 2016 |