FDA 510(k) Application Details - K103148

Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic

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510(K) Number K103148
Device Name System, Imaging, Pulsed Echo, Ultrasonic
Applicant PANASONIC HEALTHCARE CO., LTD.
2425 SQUAK MOUNTAIN LOOP SW
ISSAQUAH, WA 98027 US
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Contact RAM BEDI
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Regulation Number 892.1560

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Classification Product Code IYO
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Date Received 10/25/2010
Decision Date 03/11/2011
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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