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FDA 510(k), K163510, Poseidon Ultrasound System
FDA 510(k), K163510, Poseidon Ultrasound System
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510(K) Number: K163510
Device Name: Poseidon Ultrasound System
Manufacturer: BUTTERFLY NETWORK, INC.
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
Regulation Number: 892.1550
Classification Product Code: IYN
Date Received: 12/15/2016
Decision Date: 09/06/2017
Regulation Medical Specialty: Radiology
Device Name: Poseidon Ultrasound System
Manufacturer: BUTTERFLY NETWORK, INC.
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
Regulation Number: 892.1550
Classification Product Code: IYN
Date Received: 12/15/2016
Decision Date: 09/06/2017
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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