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FDA 510(k) Application Details - K080234
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K080234
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
TERATECH CORP.
77-79 TERRACE HALL AVE.
BURLINGTON, MA 01803 US
Other 510(k) Applications for this Company
Regulation Number
892.1560
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Classification Product Code
IYO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/30/2008
Decision Date
02/14/2008
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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