DeviceClearance

Product code BZR— Anesthesiology

AIR ENTRAINER 900RT008

Classification name
Mixer, Breathing Gases, Anesthesia Inhalation
Device class
Class 2
Regulation
21 CFR 868.5330
Advisory panel
Anesthesiology
Total cleared
55
First cleared
Most recent

Market context for product code BZR

FDA has cleared 55 devices under product code BZR between 1976 and 2025, filed by 40 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 BZR

Recent clearances under product code BZR

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