FDA Registration
Active
🇺🇸 United States
Sensinel CPM Mobile Application
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
- K243216
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 |
|---|---|---|---|---|---|
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2025-03-11 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-03-11 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2025-03-11 |
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2025-03-11 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2025-03-11 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2025-03-11 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2025-03-11 |
Proprietary Names
Sensinel CPM Mobile Application
Sensinel CPM Web Application
Sensinel CPM System
Sensinel CPM Base Station
Sensinel CPM Adhesives
Sensinel CPM Wearable
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device