Catalog Number

-

Brand Name

SonoBook Series Diagnostic Ultrasound Systems

Version/Model Number

SonoBook 9

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"

-

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

K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374,K170374

Product Code

IYN

Product Code Name

System, Imaging, Pulsed Doppler, Ultrasonic

Public Device Record Key

fcaa5706-41db-49e6-8b66-7dc02a1b43fa

Public Version Date

September 05, 2022

Public Version Number

5

DI Record Publish Date

February 02, 2018

Package DI Number

06945121411981

Quantity per Package

1

Contains DI Package

06945121411172

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-