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

Hearing Aid, Group And Auditory Trainer

21 CFR 874.3320 / Ear, Nose, Throat
FDA source (opens on fda.gov)

EPF is the FDA product code for Hearing Aid, Group And Auditory Trainer, a class II device type, regulated under 21 CFR 874.3320. As of , FDA records hold 32 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EPF
Device name
Hearing Aid, Group And Auditory Trainer
Regulation
21 CFR 874.3320
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
32
Ingested recalls
0

Clearances, product code EPF

By decision year
32 clearances under product code EPF with a decision year between 1977 and 2014, 1992 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code EPF by decision year
YearClearances
19772
19781
19811
19822
19832
19861
19882
19891
19913
19927
19942
19951
19961
19972
19983
20141

Applicants with the most clearances

Product code EPF
Applicants holding the most 510(k) clearances under product code EPF
ApplicantClearances
Phonic Ear, Inc.12
Telex Communications, Inc.7
Hc Electronics3
Williams Sound, LLC2
Accutone, Inc.1
Biotone International, Inc.1
High Country Ent.1
Hypersound Health, Inc.1
Maxi-Aids, Inc.1
Metavox, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code