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FDA 510(k) Application Details - K072075
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K072075
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
GENERAL ELECTRIC CO.
9900 INNOVATION DRIVE
MAIL CODE: RP-2138
WAUWATOSA, WI 53226 US
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Contact
ALLEN SCHUH
Other 510(k) Applications for this Contact
Regulation Number
892.1550
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Classification Product Code
IYN
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More FDA Info for this Product Code
Date Received
07/30/2007
Decision Date
08/29/2007
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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