Atlas FDA

LRB

24 FDA 510(k) clearances · Product code

96 daysmedian time to decision
188 days90th percentile
24clearances measured

FDA profile

Official device name
Face Plate Hearing Aid
Device class
Class I (low risk)
Regulation
21 CFR 874.3300
Medical specialty
Ear, Nose, Throat
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RecordFirmDate
FACEPLATE ASSEMBLY (K974219)Finetone Hearing Instruments1998-02-20
INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS (K961593)Segi Hearing Aid Co.1996-11-07
MODULE PROGRAM (K942722)Electone, Inc.1994-09-06
AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) (K942236)Audina Hearing Instrument1994-06-17
ARTISAN PROGRAMMER & HEARING AID (K935048)Telex Communications, Inc.1994-02-09
GOLD AF MODULE, ITE (K933038)Electone, Inc.1993-08-02
GOLD CD MODULE, ITE (K933040)Electone, Inc.1993-08-02
SILVER RECHARGEABLE MODULE, ITE (K933045)Electone, Inc.1993-08-02
SILVER L MODULE, ITE (K933046)Electone, Inc.1993-08-02
SILVER PPP MODULE, ITE (K933043)Electone, Inc.1993-08-02
GOLD L MODULE, ITE (K933039)Electone, Inc.1993-08-02
GOLD K AMP, ITE (K933037)Electone, Inc.1993-08-02
SILVER LD MODULE, ITE (K933044)Electone, Inc.1993-08-02
FACEPLATE ITE HEARING AID MODEL 28A (K910901)Telex Communications, Inc.1991-05-30
FACEPLATE ITE HEARING AID MODEL TCA (K910900)Telex Communications, Inc.1991-05-30
OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID (K897023)Audina Hearing Instrument1990-03-16
OLYMPIA FACEPLATE MODULE (K896304)Olympia Instruments, Inc.1990-01-26
STARKEY MODEL P1 MODULE (K873031)Starkey Laboratories, Inc.1988-02-08
AIR CONDUCTION IN-THE-EAR HEARING AID UA/115/SCR (K872645)Richards Medical Co., Inc.1987-12-08
SERVICE MASTER (IMPULSE) (K873300)Richards Medical Co., Inc.1987-12-08
IN THE EAR & IN THE CANAL HEARING AID FACE PLATE (K871884)Hearing Services, Inc.1987-10-27
FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, FPR (K862769)Maico Hearing Instruments, Inc.1986-08-13
FACEPLATE, CUSTOM IN-THE-EAR HEARING AID, MCA10 (K862768)Maico Hearing Instruments, Inc.1986-08-13
RELIABLE (K834479)Reliable Hearing Aide1984-07-11

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Every clearance here is in the API, with alerts when new ones post.