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510(k) K230346

Voluson SWIFT; Voluson SWIFT+ by Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2023
Date Received
February 8, 2023
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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