Hokanson - PHOTOTRANSDUCER; 4 PIN CONNECTOR - A - D.E.HOKANSON, INC.

Duns Number:071829634

Device Description: PHOTOTRANSDUCER; 4 PIN CONNECTOR - A plethysmograph sensor that attaches to an electronic PHOTOTRANSDUCER; 4 PIN CONNECTOR - A plethysmograph sensor that attaches to an electronic plethysmograph instrument, used to measure volume changes due to blood flow changes in a limb or digit. The plethysmograph instrument measures the signal to determine changes in blood volume in the tissue under the sensor.

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More Product Details

Catalog Number

01546

Brand Name

Hokanson

Version/Model Number

PPG sensor 4 Pin

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DSB

Product Code Name

Plethysmograph, Impedance

Device Record Status

Public Device Record Key

93c8e5a5-3fb7-4427-902d-42f16d0f75e2

Public Version Date

October 05, 2020

Public Version Number

3

DI Record Publish Date

March 01, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"D.E.HOKANSON, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 218