Catalog Number

-

Brand Name

Summit Doppler

Version/Model Number

PPG

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

K060410

Product Code

JAF

Product Code Name

Monitor, Ultrasonic, Nonfetal

Public Device Record Key

aa4b4319-c7f7-4f1d-9c3f-de5a097848fe

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-