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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Stammering
510(k) Number K942651
Device Name BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS
Applicant
Casa Futura Technologies
18510 Decatur Dr.
Monte Sereno,  CA  95030
Applicant Contact THOMAS DAVID KEHOE
Correspondent
Casa Futura Technologies
18510 Decatur Dr.
Monte Sereno,  CA  95030
Correspondent Contact THOMAS DAVID KEHOE
Regulation Number874.5840
Classification Product Code
KTH  
Date Received06/03/1994
Decision Date 10/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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