The CardioSen’C is a personal, hand-held device, enabling an individual to immediately transmit a 12-lead ECG from anywhere and anytime, to a physician's office, hospital or monitoring…
The CardioSen’C is a personal, hand-held device, enabling an individual to immediately transmit a 12-lead ECG from anywhere and anytime, to a physician’s office, hospital or monitoring center. The ECG measurement can be transmitted in real time via two distinct channels. The CardioSen’C produces an ECG-modulated acoustical tone that can be coupled with and transmitted by a standard or a cellular telephone. The data can also be transmitted digitally through a cellular telephone network by use of the device’sintegrated cellular modem. Either one of these two transmissions permits the complete and reliable transfer of a 12-lead ECG immediately to a certified medical body capable of interpreting the results.
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Liaoning (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for CardioSen’C | Listed by | SHL TeleMedicine International, Israel |
| FDA product code | DXH |
| Device type | Transmitters And Receivers, Electrocardiograph, Telephone |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2920 |
| Establishment | Manufacturer |
| 510(k) | K080047 |
| Record published | 2023-08-21 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 15 to 93 % RH; Handling environment temperature 5 to 40 °C; Storage environment humidity 10 to 93 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature -25 to 70 °C |
| Sizes | Weight 300 g; height 4 cm; width 7 cm; length 13 cm |
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.