DeviceClearance

Product code HKM— Ophthalmic

GENERATED RETINAL REFLEX IMAGERY SYS

Classification name
Retinoscope, Battery-Powered
Device class
Class 1
Regulation
21 CFR 886.1780
Advisory panel
Ophthalmic
Total cleared
7
First cleared
Most recent

Market context for product code HKM

FDA has cleared 7 devices under product code HKM between 1984 and 1997, filed by 3 applicant companies. 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.

Clearances per year

Top applicants under product code HKM

Recent clearances under product code HKM

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