DeviceClearance

Product code BYG— Anesthesiology

DISPOSABLE FACE MASK

Classification name
Mask, Oxygen
Device class
Class 1
Regulation
21 CFR 868.5580
Advisory panel
Anesthesiology
Total cleared
55
First cleared
Most recent

Market context for product code BYG

FDA has cleared 55 devices under product code BYG between 1976 and 1996, filed by 37 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

last 15 years

Top applicants under product code BYG

Recent clearances under product code BYG

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