HJX — Reader, Prism, Ophthalmic Class I
FDA product code HJX covers "Reader, Prism, Ophthalmic", a Class I medical device regulated under 21 CFR 886.5810. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- HJX
- Device Class
- Class I
- Regulation Number
- 886.5810
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K000544 | labtician ophthalmics | BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 | March 9, 2000 |