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510(k) K112022

DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM by Advanced Instrumentations, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2011
Date Received
July 15, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

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  • K112529 — TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER (October 27, 2011)
  • K111934 — PD-100 SERIES ULTRASONIC POCKET DOPPLER (September 22, 2011)

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