FDA 510(k) Application Details - K053084

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K053084
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant KONTRON MEDICAL SYSTEMS SAS
17725 N.E. 65TH STREET
BLDG. C
REDMOND, WA 98052-4911 US
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Contact LARRY WALKER
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 11/02/2005
Decision Date 11/16/2005
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 Y
Expedited Review



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