FDA Registration
Active
🇨🇳 China
Patient Monitor models iM50,iM80
Reg #: 3003971136
·
FEI: 3003971136
·
Expires 2025
Products
14
Proprietary Names
1
Establishment Types
1
Classifications
14
Registration Details
- Registration Name
- EDAN INSTRUMENTS, INC.
- Registration Number
- 3003971136
- FEI Number
- 3003971136
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K113623
Owner / Operator
- Firm Name
- EDAN INSTRUMENTS, INC.
- Operator Number
- 9055347
- Address
- #15 Jinhui Road,Jinsha Community, Kengzi Sub-District, Pingshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518122
- Country
- CN
US Agent
- Business Name
- Edan Diagnostics, Inc
- Contact Name
- Chao Lin
- Address
- 9918 Via Pasar, San Diego CA
- City
- San Diego
- State
- CA
- ZIP
- 92126
- Country
- US
- [email protected]
- Phone
- 858 7503066
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2012-03-08 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2012-03-08 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2012-03-08 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2012-03-08 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2012-03-08 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | CBS | Class 2 | Anesthesiology | No | 2012-03-08 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2012-03-08 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2012-03-08 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2012-03-08 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2012-03-08 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | CBR | Class 2 | Anesthesiology | No | 2012-03-08 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2012-03-08 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2012-03-08 |
| Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | CBQ | Class 2 | Anesthesiology | No | 2012-03-08 |
Proprietary Names
Patient Monitor models iM50,iM80
Establishment Types
Manufacture Medical Device