Catalog Number

S60780

Brand Name

Serenity PZ01 Piezo Sensor, 1.5mm DIN, 2.0m

Version/Model Number

PZ01

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

K181709

Product Code

OLV

Product Code Name

Standard Polysomnograph With Electroencephalograph

Public Device Record Key

3653cffe-1e21-4992-8912-7100e59e9ace

Public Version Date

January 28, 2019

Public Version Number

1

DI Record Publish Date

December 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-