Catalog Number

-

Brand Name

CO-Pilot™ Wireless Handheld Multi-Parameter System

Version/Model Number

H500-SP-BLE sensor lock

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K192900

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

bf57da0f-a0ae-41e1-9065-c7fe82241222

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

October 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-