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FDA 510(k) Application Details - K133174
Device Classification Name
More FDA Info for this Device
510(K) Number
K133174
Device Name
ORTHOSCAN FD MINI C-ARM
Applicant
ORTHOSCAN, INC.
8212 E Evans Rd
8224 E Evans Rd
SCOTTSDALE, AZ 85260 US
Other 510(k) Applications for this Company
Contact
ADAM MENZIES
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OXO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/17/2013
Decision Date
03/28/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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