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FDA 510(k) Application Details - K121564
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K121564
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
P.O. BOX 610
CENTER VALLEY, PA 18034-0610 US
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Contact
LAURA STORMS-TYLER
Other 510(k) Applications for this Contact
Regulation Number
892.1550
More FDA Info for this Regulation Number
Classification Product Code
IYN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/29/2012
Decision Date
10/16/2012
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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