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

Air-Handling Apparatus Accessory

21 CFR 878.5080 / General, Plastic Surgery
FDA source (opens on fda.gov)

QGI is the FDA product code for Air-Handling Apparatus Accessory, a class I device type, regulated under 21 CFR 878.5080. FDA's definition for this code reads: "An air-handling apparatus accessory is a supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides an interface between the components of the device or can be used to switch electrical power. This generic type of device includes fittings...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QGI
Device name
Air-Handling Apparatus Accessory
FDA definition
An air-handling apparatus accessory is a supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room. This device provides an interface between the components of the device or can be used to switch electrical power. This generic type of device includes fittings, adapters, couplers, remote switches, and footswitches.
Regulation
21 CFR 878.5080
Device class
Class I
Review panel
General, Plastic Surgery
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