QLV · Class I — Low Risk (general controls) · Neurology · 21 CFR 882.4565
Classification
FDA Product Code
QLV
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 882.4565
Review panel
EN
Medical specialty
Neurology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.