FDA 510(k) Application Details - K140693

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K140693
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant GE MEDICAL SYSYEMS ULTRASOUND & PRIMARY CARE DIAGN
9900 Innovation Drive
Wauwatosa, WI 53226 US
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Contact TRACEY ORTIZ
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 03/19/2014
Decision Date 05/16/2014
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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