QLV

Field Generator Positioning Device

Product code
QLV
Device name
Field Generator Positioning Device
Device class
Class 1
21 CFR
21 CFR 882.4565
Medical specialty
Neurology
Marketing pathway
510(K) Exempt

FDA classification definition

An accessory or a group of accessories that operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, to manually position the Field Generator of a Navigation System in proximity to a patient.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QLV
Classification and pathway per current FDA publications. Data from openFDA (CC0).