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FDA 510(k) Application Details - K221347
Device Classification Name
More FDA Info for this Device
510(K) Number
K221347
Device Name
Transpara 1.7.2
Applicant
ScreenPoint Medical B.V.
Mercator II, 7th floor, Teornooiveld 300
Nijmegen 6525EC NL
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Contact
Robin Barwegen
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QDQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/09/2022
Decision Date
08/03/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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