R2 Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 9
What R2 Corp. makes
R2 Corp. manufactures medical cables, adapters, and electrodes designed for electrocardiogram (ECG) monitoring and electrosurgical procedures. Their product line includes ECG electrode sets, return electrodes for electrosurgery, cable adapters for ECG and electrosurgical units, and specialized monitoring electrodes like the Magnatrode. These components are intended for use in cardiac monitoring and surgical applications requiring precise electrical connectivity.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States, where they are subject to compliance with FDA requirements for electrical safety, performance, and labeling. The portfolio is not registered in any additional global regulatory databases beyond the FDA’s 510(k) clearance process.
Catalogue
R2(Tm) Ecg Electrode Set-#'S305-306 Etc. Ref K800930
510(k) 510(k)R2 Electrosurg. Return Elect. #225ETC. Ref K800933
510(k) 510(k)R2 Plate Type Cable-Adaptor #s 175, 176 Ref K800937
510(k) 510(k)Ecg-Rf-Choke Cable-Adapter #'s 121, 120 Ref K800932
510(k) 510(k)R2(Tm) Ecg Cable-Adaptor #'s 120-121-122 Ref K800931
510(k) 510(k)R2 Esu Cable-Adapter Models 160, 161 Ref K800934
510(k) 510(k)Magnatrode Cardiac Monitoring Electrode Ref K832516
510(k) 510(k)R2 Paddle Type Cable-Adaptor #s 170, 171 Ref K800936
510(k) 510(k)R2 Apex-Post., Ant.&Post. Elect.(12 Mods) Ref K800935
510(k) 510(k)
Frequently asked questions
How many devices does R2 Corp. have in the registry?
The registry currently lists 9 devices for R2 Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list R2 Corp.'s devices?
Among its 9 most recently registered devices, R2 Corp. has devices listed in FDA 510(k) (9 devices).
What risk classes do R2 Corp.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for R2 Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from R2 Corp. in the registry?
The most recently registered devices listed for R2 Corp. include R2(TM) ECG ELECTRODE SET-#'S305-306 ETC., R2 ELECTROSURG. RETURN ELECT. #225ETC., R2 PLATE TYPE CABLE-ADAPTOR #S 175, 176 and ECG-RF-CHOKE CABLE-ADAPTER #'S 121, 120.