Catalog Number

01563

Brand Name

Hokanson

Version/Model Number

MD35 Doppler Probe

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 10, 2017

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K896034

Product Code

DSB

Product Code Name

Plethysmograph, Impedance

Public Device Record Key

39e476c8-8de4-40ba-863a-79055d675be2

Public Version Date

October 05, 2020

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-