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510(k) K140729

APLIO ARTIDA, V3.2 by Toshiba America Medical Systems, In.C — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2014
Date Received
March 24, 2014
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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  • K122109 — AQUILION ONE VISION, V4.90 (September 21, 2012)
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