Rotek Corp.
United StatesFDA applicant, unverified
- Devices
- 2
What Rotek Corp. makes
Rotek Corp. manufactures tracheostomy collars, which are medical devices designed to secure tracheostomy tubes in place for patients requiring long-term respiratory support.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Trach Collar Ref K904974
Regimes: 510(k) Registry: 510(k)Trach Collar Ref K872832
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Rotek Corp. have in the registry?
The registry currently lists 2 devices for Rotek Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rotek Corp.'s devices?
Among its 2 most recently registered devices, Rotek Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Rotek Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Rotek Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Rotek Corp. in the registry?
The most recently registered devices listed for Rotek Corp. include TRACH COLLAR.