Product code CBN— Anesthesiology

ISO-GARD MASK

Classification name
Apparatus, Gas-Scavenging
Device class
Class 2
Regulation
21 CFR 868.5430
Advisory panel
Anesthesiology
Total cleared
43
First cleared
Most recent

Market context for product code CBN

FDA has cleared 43 devices under product code CBN between 1976 and 2023, filed by 34 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 CBN

Recent clearances under product code CBN

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