IDx-DR v2.3— 510(k) K213037
Substantially EquivalentDigital Diagnostics, Inc.
FDA 510(k) clearance K213037 for IDx-DR v2.3, Substantially Equivalent on 2022-06-17. Applicant: Digital Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Digital Diagnostics, Inc.
- Product code
- Code PIB
- Device class
- Class 2
- Regulation
- 21 CFR 886.1100
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Coralville, IA, US
Recent devices under product code PIB
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