ECG wireless mobile system. Battery life: 4 hour. Fast charger.Includes: 3" prin - Mobile PC-ECG 1200 System for Resting-ECG, based - NORAV MEDICAL LTD.

Duns Number:514773159

Device Description: Mobile PC-ECG 1200 System for Resting-ECG, based on an All-in-One-PC with 21" Touch Screen Mobile PC-ECG 1200 System for Resting-ECG, based on an All-in-One-PC with 21" Touch Screen, rechargeable Battery and built-in ECG Acquisition Unit.

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More Product Details

Catalog Number

ECG-LAN-GREEN-K-00-01

Brand Name

ECG wireless mobile system. Battery life: 4 hour. Fast charger.Includes: 3" prin

Version/Model Number

ECG-LAN (Green)

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

K000404

Product Code Details

Product Code

MWI

Product Code Name

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

Device Record Status

Public Device Record Key

66f264ad-a1e5-492f-80d9-e6537c67e951

Public Version Date

March 10, 2021

Public Version Number

7

DI Record Publish Date

January 03, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORAV MEDICAL LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 213