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

Device, Positive Pressure Breathing, Intermittent

21 CFR 868.5905 / Anesthesiology
FDA source (opens on fda.gov)

NHJ is the FDA product code for Device, Positive Pressure Breathing, Intermittent, a class II device type, regulated under 21 CFR 868.5905. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
NHJ
Device name
Device, Positive Pressure Breathing, Intermittent
Regulation
21 CFR 868.5905
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
26
Ingested recalls
17

Clearances, product code NHJ

By decision year
26 clearances under product code NHJ with a decision year between 1978 and 2026, 2014 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code NHJ by decision year
YearClearances
19781
19891
19911
19921
19982
20001
20011
20051
20081
20122
20132
20143
20161
20203
20221
20241
20251
20262

Applicants with the most clearances

Product code NHJ
Applicants holding the most 510(k) clearances under product code NHJ
ApplicantClearances
Hill-Rom Services Pte, Ltd.4
Dima Italia SRL3
Vortran Medical Technology 1, Inc3
Abmrc LLC2
J. H. Emerson Co.2
Lung Assist, Inc.2
Percussionaire Corp.2
Abmrc, LLC1
Abmrc, LLC1
Breas Medical AB1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order