HRK
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Table, Instrument, Manual, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4855
- Medical specialty
- Ophthalmic
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AMER. EDWARDS LAB FLEXISCOPE (K842410) | American Edwards Laboratories | 1984-11-05 |
| EVANS ARM AND HAND REST (K760697) | Alcon Laboratories | 1976-11-02 |
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Every clearance here is in the API, with alerts when new ones post.