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FDA 510(k) Application Details - K081802
Device Classification Name
Transducer, Ultrasonic, Diagnostic
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510(K) Number
K081802
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
PHILIPS ULTRASOUND, INC.
22100 BOTHELL EVERETT HWY.
BOTHELL, WA 98021 US
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Contact
ROB BUTLER
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Regulation Number
892.1570
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Classification Product Code
ITX
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More FDA Info for this Product Code
Date Received
06/26/2008
Decision Date
07/11/2008
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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