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510(k) K973861

Device
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48
Applicant
MAGNATONE HEARING AID CORP.
510(k) number
K973861
Product code
ESD  
Decision
Substantially Equivalent (SESE)
Decision date
1997-11-19
Date received
1997-10-09
Regulation
874.3300
Classification name
Hearing Aid, Air Conduction
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
DON E K. CAMPBELL
Address
P.O. Box 180964 Casselberry FL US 32718 32718

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

Legacy Summary#

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FDA Review#

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