Identity
- Trade Name
- PHILIPS FR2 3-Lead ECG, AAMI FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- FR2 ECG Assessment Module, AAMI FDA UDI
- Model / Reference
- M3873A FDA UDI
- Description
- FR2 ECG Assessment Module, AAMI FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838049956 FDA UDI
- 510(k) Number
- K013425 FDA UDI
- FDA Product Code
- MKJ FDA UDI
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 870.5310 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
PHILIPS FR2 3-Lead ECG, AAMI by Philips Electronics North America Corporation — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 III | Pending data |
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Manufacturer
- Manufacturer
- Philips Electronics North America Corporation
Sources (1)
- FDA UDI 600ce970-c7fe-4b90-a404-06c41fe95f21 35 fields · synced May 30, 2026