Q Patch Mobile Application - Q Patch Mobile Application (Mobile application) – - MEDICALGORITHMICS S A

Duns Number:522657576

Device Description: Q Patch Mobile Application (Mobile application) – The Q Patch Mobile Application is intend Q Patch Mobile Application (Mobile application) – The Q Patch Mobile Application is intended to be used for interacting with the Q Patch recorder for transmission patient data to set up ECG recording session and displaying the Q Patch’s status. The application is obligatory for healthcare professionals and optional for patients

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More Product Details

Catalog Number

-

Brand Name

Q Patch Mobile Application

Version/Model Number

1.0

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K210758

Product Code Details

Product Code

MWJ

Product Code Name

Electrocardiograph, Ambulatory (Without Analysis)

Device Record Status

Public Device Record Key

08317455-ab56-4082-b1c9-37dd29998b28

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

June 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICALGORITHMICS S A" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16