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FDA 510(k), K202406, Butterfly iQ Ultrasound System
FDA 510(k), K202406, Butterfly iQ Ultrasound System
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510(K) Number: K202406
Device Name: Butterfly iQ Ultrasound System
Manufacturer: Butterfly Network, Inc.
Device Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic
Regulation Number: 892.1550
Classification Product Code: IYN
Date Received: 08/21/2020
Decision Date: 09/16/2020
Regulation Medical Specialty: Radiology
Device Name: Butterfly iQ Ultrasound System
Manufacturer: Butterfly Network, Inc.
Device Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic
Regulation Number: 892.1550
Classification Product Code: IYN
Date Received: 08/21/2020
Decision Date: 09/16/2020
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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