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

Mechanical Ventilator

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

ONZ is the FDA product code for Mechanical Ventilator, a class II device type, regulated under 21 CFR 868.5895. FDA's definition for this code reads: "This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ONZ
Device name
Mechanical Ventilator
FDA definition
This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code ONZ

By decision year
6 clearances under product code ONZ with a decision year between 2009 and 2016, 2010 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ONZ by decision year
YearClearances
20091
20102
20111
20141
20161

Applicants with the most clearances

Product code ONZ
Applicants holding the most 510(k) clearances under product code ONZ
ApplicantClearances
Breathe Technologies, Inc.5
New Aera, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code