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EventCare

FDA UDI

Class II (US FDA UDI)

by Scottcare Corporation, The

Identity

Trade Name
EventCare FDA UDI
Generic Name
Cardiology information system application software FDA UDI
Device Name
The EventCare Event Monitoring System allows for the performance of traditional acoustic arrhythmia monitoring and the utilization of cellular event transmissions and monitoring. The system helps to maintain an accurate inventory of devices, patients’ records ECG events and reports. The system can also produce a wide array of administrative reports 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 or recorded ECG transmissions over ordinary telephone lines, as well as cellular telephony networks, edit the ECG right on the computer screen, then print out a detailed, professional report. FDA UDI
Model / Reference
EventCare FDA UDI
Description
The EventCare Event Monitoring System allows for the performance of traditional acoustic arrhythmia monitoring and the utilization of cellular event transmissions and monitoring. The system helps to maintain an accurate inventory of devices, patients’ records ECG events and reports. The system can also produce a wide array of administrative reports 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 or recorded ECG transmissions over ordinary telephone lines, as well as cellular telephony networks, edit the ECG right on the computer screen, then print out a detailed, professional report. FDA UDI

Identifiers

Catalog Number
100792 FDA UDI
Primary DI / UDI-DI
00856298006190 FDA UDI
510(k) Number
K061780 FDA UDI
FDA Product Code
DXH FDA UDI
GMDN Term
Cardiology information system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2920 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiology information system application software

EventCare by Scottcare Corporation, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiology information system application software.

Cleared under the same submission

K061780 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scottcare Corporation, The

Sources (1)

  • FDA UDI 97b7364f-d4ea-4ee4-8d0e-19dae3b62743 36 fields · synced May 30, 2026