FDA Registration
Active
🇺🇸 United States
Portrait Clinical Alarming Unit (Portrait CAU01)
Reg #: 2183613
·
FEI: 2183613
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- NORTECH SYSTEMS, INC.
- Registration Number
- 2183613
- FEI Number
- 2183613
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 925 SIXTH AVENUE NE
- City
- Milaca
- State
- MN
- ZIP
- 56353
- Country
- US
Regulatory Submissions
- 510(k) Number
- K234130
Owner / Operator
- Firm Name
- Nortech Systems, Inc.
- Operator Number
- 10032390
- Address
- 925 6th Ave NE
- City
- Milaca
- State
- MN
- Postal Code
- 56353
- Country
- US
- Correspondent
- Albert Schafer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2024-09-03 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2024-09-03 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-09-03 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2024-09-03 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2024-09-03 |
Proprietary Names
Portrait Clinical Alarming Unit (Portrait CAU01)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)