FDA Registration
Active
🇺🇸 United States
Engage Medical Device Alert Notification System
Reg #: 1831750
·
FEI: 1831750
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- STRYKER MEDICAL
- Registration Number
- 1831750
- FEI Number
- 1831750
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3800 E. CENTRE AVE.
- City
- Portage
- State
- MI
- ZIP
- 49002
- 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
Complaint File Establishment per 21 CFR 820.198