HKC
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Spectacle Microscope, Low-Vision
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5540
- Medical specialty
- Ophthalmic
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BINOCULAR MAGNIFIER 2X (K830774) | Almore Intl., Inc. | 1983-04-06 |
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Every clearance here is in the API, with alerts when new ones post.