FDA Registration
Active
🇺🇸 United States
VS-900/VS-900c
Reg #: 2221819
·
FEI: 2221819
·
Expires 2025
Products
5
Proprietary Names
3
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- MINDRAY DS USA, Inc.
- Registration Number
- 2221819
- FEI Number
- 2221819
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 800 MACARTHUR BLVD.
- City
- Mahwah
- State
- NJ
- ZIP
- 07430
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182821
Owner / Operator
- Firm Name
- Mindray DS USA, Inc.
- Operator Number
- 10025908
- Address
- 800 MacArthur Blvd
- City
- Mahwah
- State
- NJ
- Postal Code
- 07430
- Country
- US
- Correspondent
- James Clifford
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2020-05-27 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2020-05-27 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-05-27 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-05-27 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2020-05-27 |
Proprietary Names
VS-900/VS-900c
Fukuda VSM
Accutorr 7
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)