Transpara— 510(k) K192287

Substantially Equivalent

Screenpoint Medical B.V.

FDA 510(k) clearance K192287 for Transpara, Substantially Equivalent on 2019-12-10. Applicant: Screenpoint Medical B.V..

Clearance details

Applicant: Screenpoint Medical B.V.
Product code: Code QDQ
Advisory panel: Radiology
Date received: 2019-08-22
Decision date: 2019-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nijmegen, NL

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