FDA Registration
Active
🇺🇸 United States
HEM-CS24-B (HEM-CS24-BZ)
Reg #: 1450057
·
FEI: 1450057
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Omron Healthcare, Inc.
- Registration Number
- 1450057
- FEI Number
- 1450057
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2895 Greenspoint Parkway
- City
- Hoffman Est
- State
- IL
- ZIP
- 60169
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182579
Owner / Operator
- Firm Name
- Omron Healthcare, Inc.
- Operator Number
- 10023760
- Address
- 2895 Greenspoint Parkway, Suite 100
- City
- Hoffman Estates
- State
- IL
- Postal Code
- 60169
- Country
- US
- Correspondent
- Terri Ingalls
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-03-19 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2019-03-19 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2019-03-19 |
Proprietary Names
HEM-CS24-B (HEM-CS24-BZ)
BP7900 (HEM-7530T-Z)
HEM-RML31-B (HEM-RML31-BZ)
Establishment Types
Repack or Relabel Medical Device