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FDA 510(k) Application Details - K072786
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K072786
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
1230 SHOREBIRD WAY
MOUNTAIN VIEW, CA 94039 US
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Contact
SHELLY PEARCE
Other 510(k) Applications for this Contact
Regulation Number
892.1570
More FDA Info for this Regulation Number
Classification Product Code
ITX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2007
Decision Date
11/13/2007
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
Y
Expedited Review
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