Algotek, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Algotek, Inc. makes
Algotek, Inc. manufactures nerve monitoring devices, including the EMG-1 Motor Nerve Monitor and the ALGO I system, designed for intraoperative and procedural assessment of nerve function.
These products are classified as Class II devices under FDA regulations and are listed via the 510(k) clearance pathway. The company is based in the United States.
Catalogue
Emg-1, Motor Nerve Monitor Ref K864408
Regimes: 510(k) Registry: 510(k)Algo I Ref K852687
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Algotek, Inc. have in the registry?
The registry currently lists 2 devices for Algotek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Algotek, Inc.'s devices?
Among its 2 most recently registered devices, Algotek, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Algotek, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Algotek, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Algotek, Inc. in the registry?
The most recently registered devices listed for Algotek, Inc. include EMG-1, MOTOR NERVE MONITOR and ALGO I.