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FDA 510(k) Application Details - K131267
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K131267
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
GE HEALTHCARE
9900 W INNOVATION DRIVE
WAUWATOSA, WI 53226 US
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Contact
BRYAN BEHN
Other 510(k) Applications for this Contact
Regulation Number
892.1550
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Classification Product Code
IYN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/03/2013
Decision Date
06/19/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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