Product code GZP— Neurology
EyeStat
- Classification name
- Stimulator, Mechanical, Evoked Response
- Device class
- Class 2
- Regulation
- 21 CFR 882.1880
- Advisory panel
- Neurology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code GZP
FDA has cleared devices under product code GZP between 1991 and 2019, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2019
- 1991
Top applicants under product code GZP
Recent clearances under product code GZP
Data sourced from openFDA. This site is unofficial and independent of the FDA.