HPE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Aid, Vision, Optical, Battery-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5915
- Medical specialty
- Ophthalmic
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ETV, ELECTRONIC VISION AID (K884540) | Sevrain-Tech, Inc. | 1989-01-19 |
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Every clearance here is in the API, with alerts when new ones post.