DeviceClearance

Product code KMG— General Hospital

AQUANOMICS, #HHU100

Classification name
Purifier, Water, Ultraviolet, Medical
Device class
Class 2
Regulation
21 CFR 880.6710
Advisory panel
General Hospital
Total cleared
9
First cleared
Most recent

Market context for product code KMG

FDA has cleared 9 devices under product code KMG between 1981 and 2001, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code KMG

Recent clearances under product code KMG

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