DeviceClearance

Product code KYR— General Hospital

DEVON COOL FACE

Classification name
Bag, Ice
Device class
Class 1
Regulation
21 CFR 880.6050
Advisory panel
General Hospital
Total cleared
4
First cleared
Most recent

Market context for product code KYR

FDA has cleared 4 devices under product code KYR between 1976 and 1984, filed by 4 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 KYR

Recent clearances under product code KYR

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