FDA 510(k) Application Details - K101149

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K101149
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant GE VINGMED ULTRASOUND AS
9900 W INNOVATION DR. RP-2138
WAUWATOSA, WI 53226 US
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Contact BRYAN BEHN
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 04/23/2010
Decision Date 10/13/2010
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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