Atlas FDA

KHL

7 FDA 510(k) clearances · Product code

99 daysmedian time to decision
195 days90th percentile
7clearances measured

FDA profile

Official device name
Hearing Aid, Master
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3330
Medical specialty
Ear, Nose, Throat
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RecordFirmDate
LORI HEARING AID SIMULATOR (K964080)Lori Medical Laboratories, Inc.1997-01-08
PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION (K911726)Bausch & Lomb, Inc.1991-10-23
RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE (K894019)Resound Corp.1989-09-21
VOROBA PROGRAMMABLE AUDITORY COMPARATOR (K860171)Voroba Technologies Assoc.1986-05-02
CRAIGWELL MASTER HEARING AID MHA (K854126)Craigwell Electronics, Ltd.1986-01-16
RIONET HEARING AID (K802812)Kindel & Anderson1980-11-26
MODEL FS1 (K790481)Starkey Laboratories, Inc.1979-04-03

Track KHL automatically

Every clearance here is in the API, with alerts when new ones post.