Decisio Health Patient Dashboard - The heart of the Decisio product is a server that - DECISIO HEALTH, INC.

Duns Number:079182575

Device Description: The heart of the Decisio product is a server that sits in the hospital’s data center. It c

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More Product Details

Catalog Number

-

Brand Name

Decisio Health Patient Dashboard

Version/Model Number

2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K142106

Product Code Details

Product Code

MWI

Product Code Name

Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Device Record Status

Public Device Record Key

d6917c38-c16f-49a3-a0cd-06e88b34a4cf

Public Version Date

October 24, 2022

Public Version Number

8

DI Record Publish Date

December 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DECISIO HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1