FDA 510(k) Application Details - K061682

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K061682
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant GENERAL ELECTRIC CO.
9900 Innovation Drive
Wauwatosa, WI 53226 US
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Contact ALLEN SCHUH
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 06/15/2006
Decision Date 07/12/2006
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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