EventCare - The EventCare Event Monitoring System allows for - SCOTTCARE CORPORATION, THE

Duns Number:808204957

Device Description: The EventCare Event Monitoring System allows for the performance of traditional acoustic a The EventCare Event Monitoring System allows for the performance of traditional acoustic arrhythmia monitoring andthe utilization of cellular event transmissions and monitoring. The system helps to maintain an accurate inventory ofdevices, patients’ records ECG events and reports. The system can also produce a wide array of administrativereports to help manage your monitoring operations. This program provides fast, accurate access to your patients’events and Electrocardiographic recordings, regardless of time or location. EventCare allows you to receive live orrecorded ECG transmissions over ordinary telephone lines, as well as cellular telephony networks, edit the ECG righton the computer screen, then print out a detailed, professional report.

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More Product Details

Catalog Number

100792

Brand Name

EventCare

Version/Model Number

EventCare

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

K061780

Product Code Details

Product Code

DXH

Product Code Name

Transmitters And Receivers, Electrocardiograph, Telephone

Device Record Status

Public Device Record Key

97b7364f-d4ea-4ee4-8d0e-19dae3b62743

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCOTTCARE CORPORATION, THE" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 32