DeviceClearance

Product code FRA— General Hospital

Purgo

Classification name
Purifier, Air, Ultraviolet, Medical
Device class
Class 2
Regulation
21 CFR 880.6500
Advisory panel
General Hospital
Total cleared
36
First cleared
Most recent

Market context for product code FRA

FDA has cleared 36 devices under product code FRA between 1987 and 2025, filed by 32 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

last 15 years

Top applicants under product code FRA

Recent clearances under product code FRA

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