Endotek Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Endotek Corp. makes
Endotek Corp. manufactures the Robertson Obturation Monitor Insuffla, a device used for monitoring insufflation pressure during procedures such as colonoscopy, and the EMG Module (EMG1) with optional speaker, designed for electromyography testing to assess muscle function.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Endotek Corp. is based in the United States.
Catalogue
Robertson Obturation Monitor Insuffla Ref K802374
Regimes: 510(k) Registry: 510(k)Emg Module, EMG1, W/Optional Speaker Ref K842124
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Endotek Corp. have in the registry?
The registry currently lists 2 devices for Endotek Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Endotek Corp.'s devices?
Among its 2 most recently registered devices, Endotek Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Endotek Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Endotek Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Endotek Corp. in the registry?
The most recently registered devices listed for Endotek Corp. include ROBERTSON OBTURATION MONITOR INSUFFLA and EMG MODULE, EMG1, W/OPTIONAL SPEAKER.