Identity
- Trade Name
- Complete Blood Pressure Monitor +EKG FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, home-use FDA UDI
- Device Name
- Blood Pressure Monitor and single channel EKG device. FDA UDI
- Model / Reference
- BP7900 FDA UDI
- Description
- Blood Pressure Monitor and single channel EKG device. FDA UDI
Identifiers
- Catalog Number
- BP7900 FDA UDI
- Primary DI / UDI-DI
- 00073796267902 FDA UDI
- FDA Product Code
- DPS FDA UDIDXH FDA UDIDXN FDA UDIQDA FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2340 FDA UDI870.2920 FDA UDI870.1130 FDA UDI870.2345 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Multiple vital physiological parameter monitoring system, home-use
Complete Blood Pressure Monitor +EKG by Omron Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182579 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Omron Healthcare, Inc.
Sources (1)
- FDA UDI 59225584-0971-4dca-8c51-346d80de5ede 36 fields · synced Jun 8, 2026