FDA Registration
Active
🇺🇸 United States
ANALOG DEVICES
Reg #: 3000130829
·
FEI: 3000130829
·
Expires 2026
Products
7
Proprietary Names
14
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- ANALOG DEVICES
- Registration Number
- 3000130829
- FEI Number
- 3000130829
- Status
- Active
- Expiry Year
- 2026
- 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 |
|---|---|---|---|---|---|
| Stethoscope, Electronic | DQD | Class 2 | Cardiovascular | No | 2024-01-30 |
| Transmitters And Receivers, Electrocardiograph, Telephone | DXH | Class 2 | Cardiovascular | No | 2024-01-30 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 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 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2024-01-30 |
Proprietary Names
Sensinel CPM Base Station
Sensinel CPM Mobile Application
Sensinel Intelligent Algorithm
Sensinel CPM Wearable
Sensinel CPM Web Application
Sensinel CPM System
Sensinel CPM Adhesives
Sensinel CPM Mobile Application Gen 1.6
Sensinel CPM Adhesives Gen 1.6
Sensinel CPM Intelligent Algorithm Gen 1.6
Sensinel CPM Wearable Gen 1.6
Sensinel CPM Base Station Gen 1.6
Sensinel CPM Web Application Gen 1.6
Sensinel CPM System Gen 1.6
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device