FDA Registration
Active
🇺🇸 United States
Sensinel CPM Base Station
Reg #: 3000130829
·
FEI: 3000130829
·
Expires 2025
Products
7
Proprietary Names
6
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- ANALOG DEVICES
- Registration Number
- 3000130829
- FEI Number
- 3000130829
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- One Analog Way
- City
- Wilmington
- State
- MA
- ZIP
- 01887
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231086
Owner / Operator
- Firm Name
- Analog Devices
- Operator Number
- 10089993
- Address
- One Analog Way
- City
- Wilmington
- State
- MA
- Postal Code
- 01887
- Country
- US
- Correspondent
- Sam Rajkumar
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2024-01-30 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2024-01-30 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2024-01-30 |
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2024-01-30 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-01-30 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2024-01-30 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2024-01-30 |
Proprietary Names
Sensinel CPM Base Station
Sensinel CPM Mobile Application
Sensinel CPM Wearable
Sensinel CPM Web Application
Sensinel CPM Adhesives
Sensinel CPM System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device