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FDA 510(k) Application Details - K211597
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
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510(K) Number
K211597
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
Philips Medical Systems
22100 Bothell Everett HWY
Bothell, WA 98021 US
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Contact
Brenna Loufek
Other 510(k) Applications for this Contact
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
05/24/2021
Decision Date
09/08/2021
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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