Catalog Number

-

Brand Name

Butterfly Network, Inc.

Version/Model Number

Butterfly iQ

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K163510

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Public Device Record Key

05f5f3b5-1366-4fc9-b7e0-cbd4c93f4764

Public Version Date

September 10, 2018

Public Version Number

1

DI Record Publish Date

August 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-