Catalog Number

-

Brand Name

Disk PPG sensor

Version/Model Number

Disk PPG sensor

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 19, 2020

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

K111416

Product Code

JOP

Product Code Name

Transducer, Ultrasonic

Public Device Record Key

d7a9b714-8203-4ea0-a469-1e72775ca8d9

Public Version Date

June 29, 2020

Public Version Number

1

DI Record Publish Date

June 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-