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..

Clearance details

Applicant: Screenpoint Medical B.V.
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2021-02-10
Decision date: 2021-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nijmegen, NL

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