FDA Registration
Active
🇬🇧 United Kingdom
Eclipse PRO cable P/N 700-0372-01 700-0373-01 700-3878-01 700-0374-01 700-0375-01 700-0376-01 700-0379-01 700-0377-01
Reg #: 9611295
·
FEI: 3002807992
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SPACELABS HEALTHCARE LTD.
- Registration Number
- 9611295
- FEI Number
- 3002807992
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit B, Foxholes Centre, JOHN TATE ROAD
- City
- HERTFORD Hertfordshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K211651
Owner / Operator
- Firm Name
- SPACELABS HEALTHCARE, INC.
- Operator Number
- 2022906
- Address
- 35301 SE CENTER STREET, --
- City
- Snoqualmie
- State
- WA
- Postal Code
- 98065
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2021-12-01 |
Proprietary Names
Eclipse PRO cable P/N 700-0372-01 700-0373-01 700-3878-01 700-0374-01 700-0375-01 700-0376-01 700-0379-01 700-0377-01
Eclipse PRO
Eclipse PRO cable P/N 700-0372-00 700-0373-00 700-3878-00 700-0374-00 700-0375-00 700-0376-00 700-0379-00 700-0377-00
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility