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510(k) K213642

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert by Ge Healthcare — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2022
Date Received
November 18, 2021
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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