HOH
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Spectacle, Operating (Loupe), Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4770
- Medical specialty
- Ophthalmic
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SURGITEL (K934494) | General Scientific Corp. | 1994-01-25 |
| LOW-POWER BINOCULAR LOUPE (K875124) | Seiler Instrument & Mfg. Co., Inc. | 1988-02-19 |
| EXETER OPERATING LOUPE (K810817) | Exeter Instruments, Inc. | 1981-04-23 |
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Every clearance here is in the API, with alerts when new ones post.