Stimulator, Mechanical, Evoked Response
The Mechanical Evoked Response Stimulator is a neurological diagnostic device that delivers controlled mechanical stimuli, such as taps or vibrations, to elicit somatosensory evoked potentials used in assessing the integrity of sensory pathways in the nervous system. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GZP under regulation 21 CFR 882.1880 in the Neurology specialty. It is eligible for third-party 510(k) review.
Basic Information
- Product Code
- GZP
- Device Class
- FDA class 2
- Regulation Number
- 882.1880
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.