Product code HOW— Ophthalmic

MODEL 5400 OPTOKINETIC STIMULATOR

Classification name
Drum, Opticokinetic
Device class
Class 1
Regulation
21 CFR 886.1200
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

Market context for product code HOW

FDA has cleared 1 device under product code HOW, all in 1982, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code HOW

Recent clearances under product code HOW

Data sourced from openFDA. This site is unofficial and independent of the FDA.