Transpara 1.7.0— 510(k) K210404

Substantially Equivalent

Screenpoint Medical B.V.

FDA 510(k) clearance K210404 for Transpara 1.7.0, Substantially Equivalent on 2021-06-02. 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
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