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510(k) K220295

ARIETTA 50 by Fujifilm Healthcare Corporation — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2022
Date Received
February 2, 2022
Clearance Type
Abbreviated
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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