Cardiac Recorders, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 8
What Cardiac Recorders, Ltd. makes
Cardiac Recorders, Ltd. manufactures cardiac monitoring and defibrillation devices, including portable cardiac recorders like the CARDIAN II CR45A and CR5 Cardiac Monitor, as well as cardiac DC defibrillators such as the CR26 series and models 2006, 2010, 2011, and 2012. Additional products include the Cardiorater CR51, CR280/45, CR281/4, and CR7, designed for electrocardiographic recording and emergency cardiac intervention.
These devices are classified under FDA Class II and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry. Cardiac Recorders, Ltd. is based in the United States.
Catalogue
Cardian Ii CR45A Ref K861621
Regimes: 510(k) Registry: 510(k)CR5 Cardiac Monitor Ref K852887
Regimes: 510(k) Registry: 510(k)Cardiorater Cr 51 Ref K853673
Regimes: 510(k) Registry: 510(k)Cr 280/45, CR281/4 Defibrillator Ref K852905
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
2006, 2010, 2011, 2012(Cardiac Dc Defibrillator) Ref K852799
Regimes: 510(k) Registry: 510(k)Cardiorater CR7 Ref K852910
Regimes: 510(k) Registry: 510(k)Cardian Iii CR6A Ref K864704
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardiac Recorders, Ltd. have in the registry?
The registry currently lists 8 devices for Cardiac Recorders, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiac Recorders, Ltd.'s devices?
Among its 8 most recently registered devices, Cardiac Recorders, Ltd. has devices listed in FDA 510(k) (8 devices).
What risk classes do Cardiac Recorders, Ltd.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Cardiac Recorders, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiac Recorders, Ltd. in the registry?
The most recently registered devices listed for Cardiac Recorders, Ltd. include CARDIAN II CR45A, CR5 CARDIAC MONITOR, CARDIORATER CR 51 and CR 280/45, CR281/4 DEFIBRILLATOR.