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FDA 510(k) Application Details - K220822
Device Classification Name
Densitometer, Bone
More FDA Info for this Device
510(K) Number
K220822
Device Name
Densitometer, Bone
Applicant
3D-Shaper Medical S.L
C/ Paris 179, 2-2
Barcelona 08036 ES
Other 510(k) Applications for this Company
Contact
Ludovic Humbert
Other 510(k) Applications for this Contact
Regulation Number
892.1170
More FDA Info for this Regulation Number
Classification Product Code
KGI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/21/2022
Decision Date
12/09/2022
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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