Product code KHL— Ear, Nose, Throat

FDA has cleared 7 devices under product code KHL between 1979 and 1997, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19971 clearance
• 19911 clearance
• 19891 clearance
• 19862 clearances
• 19801 clearance
• 19791 clearance

• Voroba Technologies Assoc.1 clearance
• Starkey Laboratories, Inc.1 clearance
• Resound Corp.1 clearance
• Lori Medical Laboratories, Inc.1 clearance
• Kindel & Anderson1 clearance
• Craigwell Electronics, Ltd.1 clearance
• Bausch & Lomb, Inc.1 clearance

• K964080 — LORI HEARING AID SIMULATORLori Medical Laboratories, Inc.·1997-01-08
• K911726 — PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATIONBausch & Lomb, Inc.·1991-10-23
• K894019 — RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTEResound Corp.·1989-09-21
• K860171 — VOROBA PROGRAMMABLE AUDITORY COMPARATORVoroba Technologies Assoc.·1986-05-02
• K854126 — CRAIGWELL MASTER HEARING AID MHACraigwell Electronics, Ltd.·1986-01-16
• K802812 — RIONET HEARING AIDKindel & Anderson·1980-11-26
• K790481 — MODEL FS1Starkey Laboratories, Inc.·1979-04-03