FDA Registration
Active
🇺🇸 United States
Sleeve Cuff Kit
Reg #: 1316463
·
FEI: 1316463
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- WELCH ALLYN, INC.
- Registration Number
- 1316463
- FEI Number
- 1316463
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 4341 STATE STREET RD.
- City
- Skaneateles Falls
- State
- NY
- ZIP
- 13153
- Country
- US
Regulatory Submissions
- 510(k) Number
- K021756
Owner / Operator
- Firm Name
- BAXTER HEALTHCARE CORPORATION
- Operator Number
- 1417572
- Address
- One Baxter Parkway
- City
- Deerfield
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Maha Nolasco
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2022-01-11 |
Proprietary Names
Sleeve Cuff Kit
ABPM 6100 service only
ABPM 6100 Sleeve Cuff, various sizes
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device