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FDA 510(k) Application Details - K181407
Device Classification Name
More FDA Info for this Device
510(K) Number
K181407
Device Name
Artis zee/zeego & Artis Q/Q.zen
Applicant
Siemens Medical Solution USA, Inc.
40 Liberty Boulevard 65-1A
Malvern, PA 19355 US
Other 510(k) Applications for this Company
Contact
Patricia D. Jones
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
05/30/2018
Decision Date
08/15/2018
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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