Ralin Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Ralin Medical, Inc. makes
Ralin Medical, Inc. manufactures cardiac event recording systems, including the CORFAX Cardiac Data Transmitter and the WristRecorder Plus. These devices are designed to remotely capture and transmit electrocardiogram (ECG) data for monitoring cardiac events in patients.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Corfax Cardiac Data Transmitter Ref K931585
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ralin Medical, Inc. have in the registry?
The registry currently lists 2 devices for Ralin Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ralin Medical, Inc.'s devices?
Among its 2 most recently registered devices, Ralin Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Ralin Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ralin Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ralin Medical, Inc. in the registry?
The most recently registered devices listed for Ralin Medical, Inc. include CORFAX CARDIAC DATA TRANSMITTER and WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM.