FDA Registration
Active
🇺🇸 United States
BeneVision Central Monitoring System with Telemetry - TD60 and TM80, and accessories
Reg #: 2221819
·
FEI: 2221819
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
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
- K183238
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 |
|---|---|---|---|---|---|
| Amplifier And Signal Conditioner, Transducer Signal | DRQ | Class 2 | Cardiovascular | No | 2019-12-12 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2019-12-12 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2019-12-12 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2019-12-12 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2019-12-12 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2019-12-12 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2019-12-12 |
Proprietary Names
BeneVision Central Monitoring System with Telemetry - TD60 and TM80, and accessories
Establishment Types
Complaint File Establishment per 21 CFR 820.198