Identity
- Trade Name
- CARDIO MONITOR CENTER VISION FDA UDI
- Generic Name
- Cardiology information system application software FDA UDI
- Device Name
- The Cardio Monitor Center Vision™ is a stand-alone medical device software operating on the physical or virtual personal computer in the organizational network and designed to work in combination with the medical device (remote personal ECG transmitter) to receive medical data (digital ECG data as an input) converting it to the interpretable ECG graph (software output). The Cardio Monitor Centre Vision displays 12 ECG leads ECG and Rhythm strip. The software received the data via proxy server and converts it to the graph of voltage versus time, displaying the heart's electrical forces, as viewed from 12 different electrical perspectives (points of view) - 12 leads, created by electrodes touching the skin. FDA UDI
- Model / Reference
- S-CV8-00 FDA UDI
- Description
- The Cardio Monitor Center Vision™ is a stand-alone medical device software operating on the physical or virtual personal computer in the organizational network and designed to work in combination with the medical device (remote personal ECG transmitter) to receive medical data (digital ECG data as an input) converting it to the interpretable ECG graph (software output). The Cardio Monitor Centre Vision displays 12 ECG leads ECG and Rhythm strip. The software received the data via proxy server and converts it to the graph of voltage versus time, displaying the heart's electrical forces, as viewed from 12 different electrical perspectives (points of view) - 12 leads, created by electrodes touching the skin. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290008960427 FDA UDI
- FDA Product Code
- DPS FDA UDI
- GMDN Term
- Cardiology information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiology information system application software
Cardio Monitor Center Vision by Shl Telemedicine International Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shl Telemedicine International Ltd.
Sources (1)
- FDA UDI 0fdfd5c1-a692-4b0b-942a-547d910847b6 34 fields · synced Jun 8, 2026