510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
KHLClass II

Hearing Aid, Master

21 CFR 874.3330 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KHL is the FDA product code for Hearing Aid, Master, a class II device type, regulated under 21 CFR 874.3330. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KHL
Device name
Hearing Aid, Master
Regulation
21 CFR 874.3330
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code KHL

By decision year
7 clearances under product code KHL with a decision year between 1979 and 1997, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KHL by decision year
YearClearances
19791
19801
19862
19891
19911
19971

Applicants with the most clearances

Product code KHL
Applicants holding the most 510(k) clearances under product code KHL
ApplicantClearances
Bausch & Lomb Incorporated1
Craigwell Electronics, Ltd.1
Kindel & Anderson1
Lori Medical Laboratories, Inc.1
Resound Corp.1
Starkey Laboratories, Inc.1
Voroba Technologies Assoc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code KHL.