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

Pump, Nebulizer, Manual

21 CFR 874.5220 / Ear, Nose, Throat
FDA source (opens on fda.gov)

EPN is the FDA product code for Pump, Nebulizer, Manual, a class I device type, regulated under 21 CFR 874.5220. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EPN
Device name
Pump, Nebulizer, Manual
Regulation
21 CFR 874.5220
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code EPN

By decision year
2 clearances under product code EPN with a decision year between 1980 and 1989, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EPN by decision year
YearClearances
19801
19891

Applicants with the most clearances

Product code EPN
Applicants holding the most 510(k) clearances under product code EPN
ApplicantClearances
Devilbiss Health Care, Inc.1
Dhd Medical Products Div. Diemolding Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order