QTW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Digital Amsler Grid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1330
- Medical specialty
- Ophthalmic
- FDA definition
- A Digital Amsler grid is intended as an aid in detection of central visual irregularities caused by changes in the visual pathway in patients.
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| Record | Firm | Date |
|---|---|---|
| EyeCTester (K203594) | Neuro-Eye Diagnostic Systems, LLC | 2022-09-07 |
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Every clearance here is in the API, with alerts when new ones post.