HIX — Maxwell Spot, Ac-Powered Class I
FDA product code HIX covers "Maxwell Spot, Ac-Powered", a Class I medical device regulated under 21 CFR 886.1435. Submissions are reviewed by the Ophthalmic panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- HIX
- Device Class
- Class I
- Regulation Number
- 886.1435
- Submission Type
- 510(k) Exempt
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No