GZP — Stimulator, Mechanical, Evoked Response Class II

FDA Device Classification

FDA product code GZP covers "Stimulator, Mechanical, Evoked Response", a Class II medical device regulated under 21 CFR 882.1880. Submissions are reviewed by the Neurology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GZP
Device Class
Class II
Regulation Number
882.1880
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K191700blinktbiEyeStatDecember 9, 2019
K913604biomagnetic technologiesSOMATOSENSORY STIMULUS SYSTEMDecember 9, 1991