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510(k) K861492

Device
Hearing Aid (all In The Ear)
Applicant
CRYSTAL TONE HEARING INSTRUMENTS
510(k) number
K861492
Product code
ESD
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-02
Date received
1986-04-22
Regulation
874.3300
Classification name
Hearing Aid, Air-Conduction, Prescription
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BRUCE P WOODARD
Address
4217 University Ave. Des Moines IA US 50311 50311

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ESD#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K232999Lyric4 Hearing AidSonova AG2024-04-11
K130790LYRIC2Phonak, LLC2013-06-27
K081136LYRIC HEARING AIDInsound Medical, Inc.2008-05-08
K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.2002-11-19
K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.2001-04-24
K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, Inc.1999-03-12
K974751TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CICGeneral Hearing Instruments, Inc.1998-03-06
K974242ARGOSY PROGRAMMABLE ONQUEArgosy Electronics1998-01-20
K973880SONIX HEARING AID FITTING AND PROGRAMMING SYSTEMSonix Technologies, Inc.1998-01-12
K974211OPUS 2 - FULL CONCHA SERIES - ITEBernafon-Maico, Inc.1997-12-15
K974152OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)Bernafon-Maico, Inc.1997-12-15
K974069OPUS 2 - CANAL SERIES (ITC)Bernafon-Maico, Inc.1997-12-15
K974340UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTEUnitron Industries, Inc.1997-12-12
K974339UNITRON MODEL SOUND F/XD PROGRAMMABLEUnitron Industries, Inc.1997-12-12
K974338UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)Unitron Industries, Inc.1997-12-12