KHL — Hearing Aid, Master Class II

FDA Device Classification

FDA product code KHL covers "Hearing Aid, Master", a Class II medical device regulated under 21 CFR 874.3330. Submissions are reviewed by the Ear, Nose, Throat panel. At least 7 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KHL
Device Class
Class II
Regulation Number
874.3330
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K964080lori medical laboratoriesLORI HEARING AID SIMULATORJanuary 8, 1997
K911726bausch and lombPROGRAMMABLE AUDITORY COMPARATOR, MODIFICATIONOctober 23, 1991
K894019resoundRESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTESeptember 21, 1989
K860171voroba technologies assocVOROBA PROGRAMMABLE AUDITORY COMPARATORMay 2, 1986
K854126craigwell electronicsCRAIGWELL MASTER HEARING AID MHAJanuary 16, 1986
K802812kindel and andersonRIONET HEARING AIDNovember 26, 1980
K790481starkey laboratoriesMODEL FS1April 3, 1979