HOW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Drum, Opticokinetic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1200
- Medical specialty
- Ophthalmic
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MODEL 5400 OPTOKINETIC STIMULATOR (K822917) | Life-Tech Intl., Inc. | 1982-11-01 |
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Every clearance here is in the API, with alerts when new ones post.