Medical Device Manufacturer · US , Mchenry , IL

Electone, Inc.

73 submissions · 73 cleared · Since 1981
73
Total
73
Cleared
0
Denied

Electone, Inc. — FDA 510(k) Submissions

Electone, Inc. has submitted 73 FDA 510(k) premarket notifications since 1981, of which 73 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hearing Aid, Air-conduction, Prescription, Face Plate Hearing Aid, I.v. Start Kit . Use the specialty filter in the sidebar to narrow results.

73 devices
1–25 of 73
Z DEQ-II
K973266 · ESD Hearing Aid,... · Ear, Nose, Throat
Sep 1997 25d
AM 400
K961084 · ESD Hearing Aid,... · Ear, Nose, Throat
Apr 1996 30d
SONATA U-01
K955702 · ESD Hearing Aid,... · Ear, Nose, Throat
Feb 1996 69d
Z20
K953047 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1995 53d
Z33
K953050 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1995 53d
Z22
K953048 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1995 46d
Z24
K953049 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1995 46d
Z35
K953051 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1995 46d
AM 260 K-AMP
K953052 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1995 46d
AM 260 PP
K953053 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1995 46d
AM 260 OHM
K953054 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1995 46d
GOLD CD ULTRA MINI CANAL - MODULE
K951642 · ESD Hearing Aid,... · Ear, Nose, Throat
Jul 1995 92d
SILVER ULTRA MINI CANAL
K950458 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1995 56d
GOLD K AMP ULTRA MINI CANAL
K950459 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1995 49d
GOLD CD ULTRA MINI CANAL
K950460 · ESD Hearing Aid,... · Ear, Nose, Throat
Mar 1995 49d
MODULE PROGRAM
K942722 · LRB Face Plate Hearing Aid · Ear, Nose, Throat
Sep 1994 89d
770-ATC
K941133 · ESD Hearing Aid,... · Ear, Nose, Throat
May 1994 64d
GOLD ASP MODULE, ITE
K933036 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1993 96d
GOLD K AMP, ITE
K933037 · LRB Face Plate Hearing Aid · Ear, Nose, Throat
Aug 1993 96d
GOLD AF MODULE, ITE
K933038 · LRB Face Plate Hearing Aid · Ear, Nose, Throat
Aug 1993 96d
GOLD L MODULE, ITE
K933039 · LRB Face Plate Hearing Aid · Ear, Nose, Throat
Aug 1993 96d
GOLD CD MODULE, ITE
K933040 · LRB Face Plate Hearing Aid · Ear, Nose, Throat
Aug 1993 96d
COLD CD ASP MODULE, ITE
K933041 · LRS I.v. Start Kit · General & Plastic Surgery
Aug 1993 96d
SILVER COMPRESSION MODULE, ITE
K933042 · ESD Hearing Aid,... · Ear, Nose, Throat
Aug 1993 96d
SILVER PPP MODULE, ITE
K933043 · LRB Face Plate Hearing Aid · Ear, Nose, Throat
Aug 1993 96d
Filters