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FDA 510(k) Application Details - K043189
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K043189
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
3G ULTRASOUND, INC.
12672 CORAL LAKES DRIVE
BOYNTON BEACH, FL 33437 US
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Contact
PAUL SCHNEIDER
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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
11/17/2004
Decision Date
02/09/2005
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
N
Expedited Review
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