FDA Registration
Active
🇺🇸 United States
Accessories - Software and Hardware
Reg #: 1316463
·
FEI: 1316463
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
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
- K132807
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 |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2022-01-11 |
Proprietary Names
Accessories - Software and Hardware
Connex Central Station (Connex CS), Model 901066 Monitoring Station and Connex CS Accessories
Establishment Types
Manufacture Medical Device