BUTTERFLY NETWORK, INC.

Address:1600 District Ave,Burlington,MA,01803,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, imaging, pulsed doppler, ultrasonic (IYN) (10) System, imaging, pulsed echo, ultrasonic (IYO) (10) Transducer, ultrasonic, diagnostic (ITX) (10)

Premarket Exempt

Clear

LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter - 00850027593005 Catalog Number :

Device Description : LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter

Device Class : 2

Duns Number: 064617010

Premarket Exempt : No

Product Code : ITX, IYO, IYN

Prescription Use : Yes

Device Count : 1

USB-C CABLE ASSEMBLY, USB 2.0, 2.50 meter - 00850027593012 Catalog Number :

Device Description : USB-C CABLE ASSEMBLY, USB 2.0, 2.50 meter

Device Class : 2

Duns Number: 064617010

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

Butterfly Network, Inc. - 00866646000206 Catalog Number :

Device Description : Portable Ultrasound System

Device Class : 2

Duns Number: 064617010

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

BUTTERFLY iQ+ - 00866646000213 Catalog Number :

Device Description : BUTTERFLY iQ+

Device Class : 2

Duns Number: 064617010

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

USB-C CABLE ASSEMBLY, USB 2.0, 1.25 meter - 00866646000220 Catalog Number :

Device Description : USB-C CABLE ASSEMBLY, USB 2.0, 1.25 meter

Device Class : 2

Duns Number: 064617010

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter - 00866646000237 Catalog Number :

Device Description : USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter

Device Class : 2

Duns Number: 064617010

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter - 00866646000244 Catalog Number :

Device Description : LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter

Device Class : 2

Duns Number: 064617010

Premarket Exempt : No

Product Code : IYN, IYO, ITX

Prescription Use : Yes

Device Count : 1

LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.00 meter - 00866646000251 Catalog Number :

Device Description : LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.00 meter

Device Class : 2

Duns Number: 064617010

Premarket Exempt : No

Product Code : IYO, IYN, ITX

Prescription Use : Yes

Device Count : 1

BUTTERFLY iQ/iQ+ WIRELESS CHARGER KIT - 00866646000268 Catalog Number :

Device Description : BUTTERFLY iQ/iQ+ WIRELESS CHARGER KIT

Device Class : 2

Duns Number: 064617010

Premarket Exempt : No

Product Code : IYN, ITX, IYO

Prescription Use : Yes

Device Count : 1

LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter - 00866646000275 Catalog Number :

Device Description : LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter

Device Class : 2

Duns Number: 064617010

Premarket Exempt : No

Product Code : ITX, IYN, IYO

Prescription Use : Yes

Device Count : 1

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