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

Continuous, Ventilator, Home Use

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

NOU is the FDA product code for Continuous, Ventilator, Home Use, a class II device type, regulated under 21 CFR 868.5895. FDA's definition for this code reads: "This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device". As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 16 recalls.

Classification record

Product code
NOU
Device name
Continuous, Ventilator, Home Use
FDA definition
This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.
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
7
Ingested recalls
16

Clearances, product code NOU

By decision year
7 clearances under product code NOU with a decision year between 2003 and 2025, 2003 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NOU by decision year
YearClearances
20032
20041
20131
20161
20211
20251

Applicants with the most clearances

Product code NOU
Applicants holding the most 510(k) clearances under product code NOU
ApplicantClearances
Breas Medical AB3
Respironics, Inc.2
GE Healthcare, Breas Medical AB1
Versamed, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order