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FDA 510(k) Application Details - K203719
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K203719
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
Volcano Corporation
3721 Valley Centre Dr Ste 500
San Diego, CA 92130 US
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Contact
Linda Schulz
Other 510(k) Applications for this Contact
Regulation Number
892.1560
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Classification Product Code
IYO
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More FDA Info for this Product Code
Date Received
12/21/2020
Decision Date
01/19/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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