Product code BXK— Anesthesiology

BLOOD GAS MIXTURE

Classification name
Gas, Calibration (Specified Concentration)
Device class
Class 1
Regulation
21 CFR 868.6400
Advisory panel
Anesthesiology
Total cleared
32
First cleared
Most recent

Market context for product code BXK

FDA has cleared 32 devices under product code BXK between 1982 and 1996, filed by 20 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 BXK

Recent clearances under product code BXK

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