FDA Registration
Active
🇺🇸 United States
gas sample lines
Reg #: 3010157426
·
FEI: 3010157426
·
Expires 2025
Products
8
Proprietary Names
3
Establishment Types
1
Classifications
8
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
- K112173
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 |
|---|---|---|---|---|---|
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2011-11-10 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2011-11-10 |
| Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) | NHO | Class 2 | Anesthesiology | No | 2011-11-10 |
| Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) | NHP | Class 2 | Anesthesiology | No | 2011-11-10 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2011-11-10 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2011-11-10 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2011-11-10 |
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | NHQ | Class 2 | Anesthesiology | No | 2011-11-10 |
Proprietary Names
gas sample lines
airway adapters
Model 92518
Establishment Types
Manufacture Medical Device