Product code KTH— Ear, Nose, Throat

FDA has cleared 4 devices under product code KTH between 1980 and 1996, filed by 4 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19961 clearance
• 19951 clearance
• 19871 clearance
• 19801 clearance

• Vocaltech C/O Hogan & Hartson1 clearance
• Surface Mount Technology, Inc.1 clearance
• Foundation For Fluency, Inc.1 clearance
• Casa Futura Technologies1 clearance

• K962961 — SUSTAINED PHONATIONSurface Mount Technology, Inc.·1996-09-09
• K942651 — BIOFEEDBACK SYSTEM FOR SPEECH DISORDERSCasa Futura Technologies·1995-10-19
• K871590 — VOCALTECH VOCAL FEEDBACK DEVICEVocaltech C/O Hogan & Hartson·1987-10-06
• K800445 — EDINBURGH MASKERFoundation For Fluency, Inc.·1980-03-12