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510(k) K942651

Device
BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS
Applicant
CASA FUTURA TECHNOLOGIES
510(k) number
K942651
Product code
KTH  
Decision
Substantially Equivalent (SESE)
Decision date
1995-10-19
Date received
1994-06-03
Regulation
874.5840
Classification name
Device, Anti-stammering
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
THOMAS DAVID KEHOE
Address
18510 Decatur Dr. Monte Sereno CA US 95030 95030

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KTH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962961SUSTAINED PHONATIONSurface Mount Technology, Inc.1996-09-09
K871590VOCALTECH VOCAL FEEDBACK DEVICEVocaltech C/O Hogan & Hartson1987-10-06
K800445EDINBURGH MASKERFoundation For Fluency, Inc.1980-03-12

Legacy Summary#

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FDA Review#

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