DeviceClearance

Product code QBE— Cardiovascular

Neuro Assessment System NAS-1000

Classification name
Cranial Sound Monitor
Device class
Class 2
Regulation
21 CFR 870.1875
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“To non-invasively detect, monitor, record and display acoustic signals in the brain.”

— U.S. Food and Drug Administration, device classification record for product code QBE under 21 CFR 870.1875, via openFDA

Market context for product code QBE

FDA has cleared 1 device under product code QBE, all in 2018, filed by 1 applicant company. 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.

Top applicants under product code QBE

Recent clearances under product code QBE

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