FDA Registration
Active
🇺🇸 United States
BleaseSirius
Reg #: 3010157426
·
FEI: 3010157426
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Spacelabs Healthcare Inc.
- Registration Number
- 3010157426
- FEI Number
- 3010157426
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 35301 SE Center St
- City
- Snoqualmie
- State
- WA
- ZIP
- 98065
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101850
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 |
|---|---|---|---|---|---|
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2012-07-13 |
Proprietary Names
BleaseSirius
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)