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FDA 510(k) Application Details - K221335
Device Classification Name
More FDA Info for this Device
510(K) Number
K221335
Device Name
D▓RS and D▓RS 9090
Applicant
Stephanix
10, rue Jean Moulin Z.I du Bayon
La Ricamarie 42150 FR
Other 510(k) Applications for this Company
Contact
Sandie Perret
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/09/2022
Decision Date
06/07/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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