Catalog Number

1014557

Brand Name

SmartMonitor 2PS w/ Modem

Version/Model Number

1014557

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

0612aa9b-cc13-4ccd-b667-b533d2a297d7

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

-