Catalog Number

1038140

Brand Name

SmartMonitor 2PSL Hospital Alarm w/ Modem

Version/Model Number

1038140

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K061256

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

acce8933-ecf7-41e1-82b5-6f234caa82ba

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 07, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-