FDA 510(k) Application Details - K990517

Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic

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510(K) Number K990517
Device Name System, Imaging, Pulsed Doppler, Ultrasonic
Applicant DIAGNOSTIC MEDICAL SYSTEMS
PO BOX 12038
LA JOLLA, CA 92039 US
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Contact FRANK FERGUSON
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Regulation Number 892.1550

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Classification Product Code IYN
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Date Received 02/18/1999
Decision Date 08/01/2000
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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