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FDA 510(k) Application Details - K063600
Device Classification Name
Monitor, Ultrasonic, Nonfetal
More FDA Info for this Device
510(K) Number
K063600
Device Name
Monitor, Ultrasonic, Nonfetal
Applicant
SUMMIT DOPPLER SYSTEMS, INC.
4620 TECHNOLOGY DR. UNIT 100
GOLDEN, CO 80403 US
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Contact
KEN JARRELL
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Regulation Number
892.1540
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Classification Product Code
JAF
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More FDA Info for this Product Code
Date Received
12/04/2006
Decision Date
12/19/2006
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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