Transoma Medical
Country not established
- Devices
- 2
What Transoma Medical makes
Transoma Medical produces implantable cardiac monitoring systems, including the SLEUTH Implantable ECG System accessory kits (8 cm) and the SLEUTH AT Implantable Cardiac Monitoring System with 6 cm and 8 cm antennas, along with Personal Diagnostic Manager (PDM) accessory kits. These devices are designed for continuous or intermittent cardiac rhythm monitoring and remote diagnostic data transmission.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Transoma Medical have in the registry?
The registry currently lists 2 devices for Transoma Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Transoma Medical's devices?
Among its 2 most recently registered devices, Transoma Medical has devices listed in FDA 510(k) (2 devices).
What risk classes do Transoma Medical's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Transoma Medical's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Transoma Medical in the registry?
The most recently registered devices listed for Transoma Medical include SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 and SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL.