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510(k) K083877

FLYING DIAGNOSTIC ULTRASOUND SYSTEM by Neusoft Medical Systems Co., Ltd. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2009
Date Received
December 29, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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