DeviceClearance

Product code BYJ— Anesthesiology

LIQUID OXYGEN SYSTEM

Classification name
Unit, Liquid-Oxygen, Portable
Device class
Class 2
Regulation
21 CFR 868.5655
Advisory panel
Anesthesiology
Total cleared
55
First cleared
Most recent

Market context for product code BYJ

FDA has cleared 55 devices under product code BYJ between 1976 and 2013, 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 BYJ

Adverse events under product code BYJ

product code BYJ
Death
16
Total
16

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code BYJ

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