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NOU — Continuous, Ventilator, Home Use Class II

FDA Device Classification

Classification Details

Product Code
NOU
Device Class
Class II
Regulation Number
868.5895
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Definition

This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233452breas medicalVivo 45 LSJanuary 13, 2025
K193586breas medicalVivo 45 LSJanuary 27, 2021
K160481breas medicalVivo 60November 9, 2016
K123144ge healthcare, breas medicalVIVO 50June 18, 2013
K034032respironics californiaPLV CONTINUUM VENTILATOR, MODEL P2000March 16, 2004
K022750respironics californiaPLV CONTINUUM VENTILATOR, MODEL P1000November 20, 2003
K021981versamedIVENT 201 PORTABLE VENTILATORAugust 13, 2003