Product code QLV

Device name

Field Generator Positioning Device

Medical specialty

Neurology

Device class

1

Regulation number

882.4565

Review panel

EN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset