FDA Registration
Active
🇺🇸 United States
Surveyor S19
Reg #: 1316463
·
FEI: 1316463
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
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
- K173765
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 |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2022-01-10 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2022-01-10 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2022-01-10 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2022-01-10 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2022-01-10 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2022-01-10 |
| Alarm, Blood-Pressure | DSJ | Class 2 | Cardiovascular | No | 2022-01-10 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2022-01-10 |
Proprietary Names
Surveyor S19
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility