DeviceClearance

Product code QAF— Cardiovascular

Cerebrotech CMS-5000

Classification name
Impedance Plethysmograph, Cranial
Device class
Class 2
Regulation
21 CFR 870.2770
Advisory panel
Cardiovascular
Total cleared
3
First cleared
Most recent

FDA classification definition

“Detect or measure variations in volume in the cranium, using tissue impedance properties.”

— U.S. Food and Drug Administration, device classification record for product code QAF under 21 CFR 870.2770, via openFDA

Market context for product code QAF

FDA has cleared 3 devices under product code QAF between 2017 and 2026, filed by 3 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 QAF

Recent clearances under product code QAF

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