HLW — Preamplifier, Battery-Powered, Ophthalmic Class II
FDA product code HLW covers "Preamplifier, Battery-Powered, Ophthalmic", a Class II medical device regulated under 21 CFR 886.1640. Submissions are reviewed by the Ophthalmic panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HLW
- Device Class
- Class II
- Regulation Number
- 886.1640
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No