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FDA 510(k) Application Details - K150037
Device Classification Name
System, Therapeutic, X-Ray
More FDA Info for this Device
510(K) Number
K150037
Device Name
System, Therapeutic, X-Ray
Applicant
SENSUS HEALTHCARE
851 BROKEN SOUND PKWY NW
#215
BOCA RATON, FL 33487 US
Other 510(k) Applications for this Company
Contact
KAL FISHERMAN
Other 510(k) Applications for this Contact
Regulation Number
892.5900
More FDA Info for this Regulation Number
Classification Product Code
JAD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/09/2015
Decision Date
10/16/2015
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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