HLT — Preamplifier, Ac-Powered, Ophthalmic Class II
FDA product code HLT covers "Preamplifier, Ac-Powered, Ophthalmic", a Class II medical device regulated under 21 CFR 886.1640. Submissions are reviewed by the Ophthalmic panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HLT
- Device Class
- Class II
- Regulation Number
- 886.1640
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K924277 | chalgren enterprises | DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING | December 7, 1994 |
| K921815 | tomey corporation usa | TOMEY PE-300 PORTABLE ERG | July 15, 1992 |
| K841293 | keller instruments | PANORAMIC LOUPES - VARIOUS | May 9, 1984 |
| K781543 | sonometrics systems | ORBIOGRAPH | October 24, 1978 |