DeviceClearance

Product code CAN— Anesthesiology

AMBU OXYGEN REGULATOR

Classification name
Regulator, Pressure, Gas Cylinder
Device class
Class 1
Regulation
21 CFR 868.2700
Advisory panel
Anesthesiology
Total cleared
55
First cleared
Most recent

Market context for product code CAN

FDA has cleared 55 devices under product code CAN between 1977 and 2017, filed by 45 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

last 15 years

Top applicants under product code CAN

Adverse events under product code CAN

product code CAN
Death
4
Other
1
Total
5

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 CAN

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