Product code HMJ— Ophthalmic

BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE

Classification name
Screen, Tangent, Projection, Battery-Powered
Device class
Class 1
Regulation
21 CFR 886.1810
Advisory panel
Ophthalmic
Total cleared
2
First cleared
Most recent

Market context for product code HMJ

FDA has cleared 2 devices under product code HMJ between 1992 and 1993, 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.

Clearances per year

Top applicants under product code HMJ

Recent clearances under product code HMJ

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