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FDA 510(k)

Poseidon Ultrasound System

K-Number: K163510 · 2017-09-06

ApplicantButterfly Network, Inc.
Decision Date2017-09-06
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Poseidon Ultrasound System is a medical device manufactured by Butterfly Network, Inc.. It received FDA 510(k) clearance on 2017-09-06 under approval number K163510. 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 Poseidon Ultrasound System?

Poseidon Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-09-06. It is manufactured by Butterfly Network, Inc.. The 510(k) number is K163510.

When was Poseidon Ultrasound System approved by the FDA?

Poseidon Ultrasound System received FDA 510(k) clearance on 2017-09-06, under approval number K163510.

What company makes Poseidon Ultrasound System?

Poseidon Ultrasound System is manufactured by Butterfly Network, Inc..

What is the FDA product code for Poseidon Ultrasound System?

The FDA product code for Poseidon Ultrasound System is IYN.

Related Clinical Trials

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Other Devices by Butterfly Network, Inc.

K202406Butterfly iQ Ultrasound System K200980Auto 3D Bladder Volume Tool K220068Butterfly iQ/iQ+ Ultrasound System K232808Butterfly iQ3 Ultrasound System K252148Butterfly Gestational Age Tool

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

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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