FDA Registration
Active
🇦🇺 Australia
SphygmoCor XCEL PWV
Reg #: 9710654
·
FEI: 3003339185
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ATCOR MEDICAL Pty Ltd
- Registration Number
- 9710654
- FEI Number
- 3003339185
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 301/55 Lime Street
- City
- SYDNEY New South Wales
- Country
- AU
Regulatory Submissions
- 510(k) Number
- K012487
Owner / Operator
- Firm Name
- ATCOR MEDICAL Pty Ltd
- Operator Number
- 9048688
- Address
- 301/55 Lime Street
- City
- Sydney
- State
- New South Wales
- Postal Code
- 2000
- Country
- AU
- Correspondent
- Revathy - Veera Raghavalu
US Agent
- Business Name
- Atcor Medical
- Contact Name
- Bob Hayes
- Address
- Suite 515, 184 Shuman Blvd
- City
- Naperville
- State
- IL
- ZIP
- 60563
- Country
- US
- [email protected]
- Phone
- 630 2288876
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2007-11-13 |
Proprietary Names
SphygmoCor XCEL PWV
SphygmoCor XCEL PWA
SphygmoCor XCEL
SphygmoCor XCEL CP
SphygmoCor XCEL PWA + PWV
SphygmoCor XCEL CP + PWV
Establishment Types
Manufacture Medical Device