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510(k) K202406

Butterfly iQ Ultrasound System by Butterfly Network, Inc. — Product Code IYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2020
Date Received
August 21, 2020
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

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  • K163510 — Poseidon Ultrasound System (September 6, 2017)

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