FDA Registration
Active
🇺🇸 United States
WellSky Blood-Emergency Issue 2020 R1
Reg #: 3006129391
·
FEI: 3006129391
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- WellSky Corporation. - Headquarters
- Registration Number
- 3006129391
- FEI Number
- 3006129391
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11300 Switzer Road, --
- City
- Overland Park
- State
- KS
- ZIP
- 66210
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK200479
Owner / Operator
- Firm Name
- WellSky Corporation
- Operator Number
- 9010846
- Address
- 11300 Switzer Road, --
- City
- Overland Park
- State
- KS
- Postal Code
- 66210
- Country
- US
- Correspondent
- David Y Stevens
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Establishment Computer Software And Accessories | MMH | Class 2 | Hematology | No | 2020-09-16 |
Proprietary Names
WellSky Blood-Emergency Issue 2020 R1
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device