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FDA 510(k) Application Details - K011315
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
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510(K) Number
K011315
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
ALOKA CO., LTD.
10 FAIRFIELD BLVD.
WALLINGFORD, CT 06492 US
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Contact
KELVIN BURROUGHS
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Regulation Number
892.1550
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Classification Product Code
IYN
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More FDA Info for this Product Code
Date Received
04/30/2001
Decision Date
05/15/2001
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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