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FDA 510(k) Application Details - K072541
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K072541
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
SENORX, INC.
11 COLUMBIA
ALISO VIEJO, CA 92656 US
Other 510(k) Applications for this Company
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
09/10/2007
Decision Date
09/25/2007
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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