FDA Registration
Active
🇨🇳 China
CMS8000 Patient Monitor
Reg #: 3006979678
·
FEI: 3006979678
·
Expires 2025
Products
10
Proprietary Names
1
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- CONTEC MEDICAL SYSTEMS CO., LTD
- Registration Number
- 3006979678
- FEI Number
- 3006979678
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.112 Qinhuang West Street, Economic and Technical Development Zone
- City
- Qinhuangdao Hebei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K101692
Owner / Operator
- Firm Name
- CONTEC MEDICAL SYSTEMS CO., LTD
- Operator Number
- 10025156
- Address
- No.112 Qinhuang West Street, Economic and Technical Development Zone
- City
- Qinhuangdao
- State
- Hebei
- Postal Code
- 066004
- Country
- CN
US Agent
- Business Name
- MID-LINK INTERNATIONAL CO., Ltd
- Contact Name
- Marco Mu
- Address
- 2219 RimlangDrive, Suite 301,
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2011-06-30 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2011-06-30 |
| Monitor, St Segment With Alarm | MLD | Class 2 | Cardiovascular | No | 2011-06-30 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2011-06-30 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2011-06-30 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2011-06-30 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2011-06-30 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2011-06-30 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2011-06-30 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2011-06-30 |
Proprietary Names
CMS8000 Patient Monitor
Establishment Types
Manufacture Medical Device