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510(k) K132059

DIAGNOSTIC ULTRASOUND SYSTEM by Advanced Instrumentations, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2013
Date Received
July 3, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type

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  • K111934 — PD-100 SERIES ULTRASONIC POCKET DOPPLER (September 22, 2011)
  • K112022 — DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM (September 22, 2011)

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