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FDA 510(k)

Auto 3D Bladder Volume Tool

K-Number: K200980 · 2020-06-11

ApplicantButterfly Network, Inc.
Decision Date2020-06-11
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Auto 3D Bladder Volume Tool is a medical device manufactured by Butterfly Network, Inc.. It received FDA 510(k) clearance on 2020-06-11 under approval number K200980. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Auto 3D Bladder Volume Tool?

Auto 3D Bladder Volume Tool is a medical device that received FDA 510(k) clearance on 2020-06-11. It is manufactured by Butterfly Network, Inc.. The 510(k) number is K200980.

When was Auto 3D Bladder Volume Tool approved by the FDA?

Auto 3D Bladder Volume Tool received FDA 510(k) clearance on 2020-06-11, under approval number K200980.

What company makes Auto 3D Bladder Volume Tool?

Auto 3D Bladder Volume Tool is manufactured by Butterfly Network, Inc..

What is the FDA product code for Auto 3D Bladder Volume Tool?

The FDA product code for Auto 3D Bladder Volume Tool is IYO.

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Related Devices (Code: IYO)

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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.

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