DeviceClearance

Product code NOU— Anesthesiology

Vivo 45 LS

Classification name
Continuous, Ventilator, Home Use
Device class
Class 2
Regulation
21 CFR 868.5895
Advisory panel
Anesthesiology
Total cleared
7
First cleared
Most recent

FDA classification definition

“This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.”

— U.S. Food and Drug Administration, device classification record for product code NOU under 21 CFR 868.5895, via openFDA

Market context for product code NOU

FDA has cleared 7 devices under product code NOU between 2003 and 2025, filed by 4 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

Top applicants under product code NOU

Adverse events under product code NOU

product code NOU
Death
65
Injury
138
Malfunction
3,664
Other
1
Total
3,868

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 NOU

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