FDA Registration
Active
🇺🇸 United States
Engage Medical Device Alert Notification System
Reg #: 3010694760
·
FEI: 3010694760
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Stryker Medical Fort Wayne
- Registration Number
- 3010694760
- FEI Number
- 3010694760
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1950 W Cook Rd Ste 101
- City
- Fort Wayne
- State
- IN
- ZIP
- 46818
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130339
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, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2022-06-07 |
Proprietary Names
Engage Medical Device Alert Notification System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device