Product code EPN— Ear, Nose, Throat

DEVILBISS MODEL 6300D

Classification name
Pump, Nebulizer, Manual
Device class
Class 1
Regulation
21 CFR 874.5220
Advisory panel
Ear, Nose, Throat
Total cleared
2
First cleared
Most recent

Market context for product code EPN

FDA has cleared 2 devices under product code EPN between 1980 and 1989, filed by 2 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 EPN

Recent clearances under product code EPN

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