FDA Registration
Active
🇺🇸 United States
AIRO Computed Tomography (CT) X-ray System
Reg #: 3007997036
·
FEI: 3007997036
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STRYKER MANUFACTURING KALAMAZOO
- Registration Number
- 3007997036
- FEI Number
- 3007997036
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6201 South Sprinkle Road
- City
- Portage
- State
- MI
- ZIP
- 49002
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180393
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2019-11-05 |
Proprietary Names
AIRO Computed Tomography (CT) X-ray System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)