Transpara— 510(k) K193229
Substantially EquivalentScreenpoint Medical B.V.
FDA 510(k) clearance K193229 for Transpara, Substantially Equivalent on 2020-03-05. Applicant: Screenpoint Medical B.V.. Device class: 2.
Clearance details
- Applicant
- Screenpoint Medical B.V.
- Product code
- Code QDQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2090
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nijmegen, NL
Recent devices under product code QDQ
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