FDA.reportPublic FDA data

BUTTERFLY NETWORK, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30101023863010102386BUTTERFLY NETWORK, INC.1N2026-01-011600 District Ave Burlington MA US 01803

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2181731942054404K232808Butterfly iQ3 Ultrasound SystemIYN2024-01-04
2181731956079299K220068Butterfly iQ/iQ+ Ultrasound SystemIYO2023-03-31
2181731984066547K202406Butterfly iQ Ultrasound SystemIYN2020-09-16
2181731516066966K200980Auto 3D Bladder Volume ToolIYO2020-06-11
2181731373857094K163510Poseidon Ultrasound SystemIYN2017-09-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYN32024-01-04
IYO22023-03-31

PMN#

GUDID#