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

Face Plate Hearing Aid

21 CFR 874.3300 / Ear, Nose, Throat
FDA source (opens on fda.gov)

LRB is the FDA product code for Face Plate Hearing Aid, a class I device type, regulated under 21 CFR 874.3300. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LRB
Device name
Face Plate Hearing Aid
Regulation
21 CFR 874.3300
Device class
Class I
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
24
Ingested recalls
0

Clearances, product code LRB

By decision year
24 clearances under product code LRB with a decision year between 1984 and 1998, 1993 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code LRB by decision year
YearClearances
19841
19862
19873
19881
19902
19912
19938
19943
19961
19981

Applicants with the most clearances

Product code LRB
Applicants holding the most 510(k) clearances under product code LRB
ApplicantClearances
Electone, Inc.9
Telex Communications, Inc.3
Audina Hearing Instrument, Inc2
Maico Hearing Instruments, Inc.2
Richards Medical Co., Inc.2
Finetone Hearing Instruments1
Hearing Services, Inc.1
Olympia Instruments, Inc.1
Reliable Hearing Aide1
Segi Hearing Aid Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order