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FDA 510(k) Application Details - K192107
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
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510(K) Number
K192107
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
Clarius Mobile Health Corp.
350 - 3605 Gilmore Way
Burnaby V5G 4X5 CA
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Contact
Brendan Seward
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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
08/05/2019
Decision Date
08/29/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
Y
Expedited Review
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