DeviceClearance

Product code KHH— Ear, Nose, Throat

AUTOMATIC CALORIC IRRIGATION SYSTEM

Classification name
Stimulator, Caloric-Air
Device class
Class 1
Regulation
21 CFR 874.1800
Advisory panel
Ear, Nose, Throat
Total cleared
7
First cleared
Most recent

Market context for product code KHH

FDA has cleared 7 devices under product code KHH between 1982 and 1995, filed by 5 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 KHH

Recent clearances under product code KHH

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