Identity
- Trade Name
- Frontier X Plus FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
- Device Name
- Single-lead ECG monitor intended to capture, store, transmit and display electrocardiogram (ECG) information for long term monitoring and evaluation. FDA UDI
- Model / Reference
- Frontier X Plus FDA UDI
- Description
- Single-lead ECG monitor intended to capture, store, transmit and display electrocardiogram (ECG) information for long term monitoring and evaluation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08908013617128 FDA UDI
- 510(k) Number
- K240794 FDA UDI
- FDA Product Code
- MLO FDA UDIDXH FDA UDIDPS FDA UDI
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 FDA UDI870.2920 FDA UDI870.2340 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiographic long-term ambulatory recording analyserTelemetric electrocardiographic ambulatory recorderElectrocardiograph, home-use
Frontier X Plus by Fourth Frontier Technologies Private Limited — 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
- Fourth Frontier Technologies Private Limited
Sources (1)
- FDA UDI 203a214f-0371-4d9c-b9a1-8afd250bf503 35 fields · synced May 31, 2026