(168 days)
CLAVIS™ is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.
CLAVIS™ is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.
The provided text is a 510(k) premarket notification letter from the FDA for the Clavis EMG device. It establishes substantial equivalence but does not contain detailed information about acceptance criteria, study methodologies, or specific performance metrics. Therefore, I cannot extract the requested information from this document.
To answer your questions, I would need access to the actual 510(k) submission summary or the associated clinical trial data, which is not present in the provided text.
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).