Ralin Laboratories, Inc.
Country not established
- Devices
- 1
What Ralin Laboratories, Inc. makes
Ralin Laboratories, Inc. manufactures the WristRecorder Cardiac Event Recording System, a portable device designed to capture and store electrocardiogram (ECG) data during cardiac events for later review by healthcare providers.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) clearance pathway. The manufacturer operates from the United States.
Catalogue
Wristrecorder Cardiac Event Recording System Ref K913600
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ralin Laboratories, Inc. have in the registry?
The registry currently lists 1 device for Ralin Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ralin Laboratories, Inc.'s devices?
Among its 1 most recently registered device, Ralin Laboratories, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Ralin Laboratories, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Ralin Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ralin Laboratories, Inc. in the registry?
The most recently registered devices listed for Ralin Laboratories, Inc. include WRISTRECORDER CARDIAC EVENT RECORDING SYSTEM.