Butterfly iQ3 Ultrasound System
K-Number: K232808 · 2024-01-04
ApplicantButterfly Network, Inc.
Decision Date2024-01-04
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Butterfly iQ3 Ultrasound System is a medical device manufactured by Butterfly Network, Inc.. It received FDA 510(k) clearance on 2024-01-04 under approval number K232808. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Butterfly iQ3 Ultrasound System?
Butterfly iQ3 Ultrasound System is a medical device that received FDA 510(k) clearance on 2024-01-04. It is manufactured by Butterfly Network, Inc.. The 510(k) number is K232808.
When was Butterfly iQ3 Ultrasound System approved by the FDA?
Butterfly iQ3 Ultrasound System received FDA 510(k) clearance on 2024-01-04, under approval number K232808.
What company makes Butterfly iQ3 Ultrasound System?
Butterfly iQ3 Ultrasound System is manufactured by Butterfly Network, Inc..
What is the FDA product code for Butterfly iQ3 Ultrasound System?
The FDA product code for Butterfly iQ3 Ultrasound System is IYN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.