Vios Monitoring System Chest Sensor
Catalogue number CS2050 Chest Sensor, listed by Murata Vios, Private Limited, India, under Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm). 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
4recalls on this code
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (1), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | Murata Vios, Private Limited, India |
|---|---|
| FDA product code | DRT |
| Device type | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| Establishment | Remanufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K172586 |
| Record published | 2020-04-02 |
| Record revised | 2025-03-24 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 80 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage environment temperature -40 to 70 °C; Handling environment atmospheric pressure 80 to 106 KiloPascal |
| Packaging | Case of 32 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CS2050 Chest Sensor | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Model 7600 | IVY Biomedical Systems, Inc. | 82 |
| Model 7800 | IVY Biomedical Systems, Inc. | 66 |
| ECG | Zoll Medical Corporation | 30 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Nihon Kohden America, Inc. | 18 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Nihon Kohden Corp. | 12 |
| Model 7600EP | IVY Biomedical Systems, Inc. | 11 |
| Propaq M | Zoll Medical Corporation | 11 |
| Model 7700 | IVY Biomedical Systems, Inc. | 11 |
| CTM-300 | IVY Biomedical Systems, Inc. | 6 |
| Cable | Zoll Medical Corporation | 5 |
| Upmm | IVY Biomedical Systems, Inc. | 4 |
| ViSi | Sotera Wireless | 4 |
Showing 12 of 43. All products under Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232354 | 2024-03-22 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Murata Vios, Private Limited | 510(k) number | 2024-08-09 | Class II | Labeling design | Batteries may deplete over time while not in use if devices are stored without being plugged in to wall outlet. Depleted batteries may lead to tablet connectivity issues. | 50 |
| Murata Vios, Private Limited | 510(k) number | 2024-04-22 | Class II | Software design | During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM | 62 units |
| Murata Vios, Private Limited | 510(k) number | 2023-06-06 | Class II | Software design | A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that connects to the L2050G Vios chest sensor device. When a failure occurs, a Pulse Ox Sensor Off warning condition will be incorrectly displayed by th | 44 systems |
| Murata Vios, Private Limited | 510(k) number | 2021-06-21 | Class II | Device Design | During the set-up and workflow to begin Vios monitoring, it has been noticed that patient vital signs and ECG waveforms can become distorted and will flicker or flash very fast. This issue only occurs on the Central Station Monitor (CSM) in | 275 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.