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510(k) K241051

Vave Wireless Ultrasound System by Vave Health, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2024
Date Received
April 17, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Vave Health, Inc.

  • K191541 — Vave Personal Ultrasound System (July 10, 2019)

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