510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QLVClass I

Field Generator Positioning Device

21 CFR 882.4565 / Neurology
FDA source (opens on fda.gov)

QLV is the FDA product code for Field Generator Positioning Device, a class I device type, regulated under 21 CFR 882.4565. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QLV
Device name
Field Generator Positioning Device
FDA 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.
Regulation
21 CFR 882.4565
Device class
Class I
Review panel
Neurology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code