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

Ventilator, Continuous, Minimal Ventilatory Support, Home Use

21 CFR 868.5895 / Anesthesiology
FDA source (opens on fda.gov)

NQY is the FDA product code for Ventilator, Continuous, Minimal Ventilatory Support, Home Use, a class II device type, regulated under 21 CFR 868.5895. FDA's definition for this code reads: "This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NQY
Device name
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
FDA definition
This continuous ventilator, which operates using a fixed or passive exhaust port, is intended to treat patients with respiratory failure in the home.
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
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

No registered establishment in MDM’s records lists product code NQY.