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FDA 510(k) Application Details - K200603
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K200603
Device Name
System, Image Processing, Radiological
Applicant
Philips Ultrasound, Inc
22100 Bothell Everett Highway
Bothell, WA 98021-8431 US
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Contact
Hebe Sun
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/09/2020
Decision Date
09/20/2020
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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