HLT
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Preamplifier, Ac-Powered, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1640
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING (K924277) | Chalgren Enterprises, Inc. | 1994-12-07 |
| TOMEY PE-300 PORTABLE ERG (K921815) | Tomey Corporation USA | 1992-07-15 |
| PANORAMIC LOUPES - VARIOUS (K841293) | Keller Instruments, Inc. | 1984-05-09 |
| ORBIOGRAPH (K781543) | Sonometrics Systems, Inc. | 1978-10-24 |
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Every clearance here is in the API, with alerts when new ones post.