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
KLXClass II

Electroglottograph

21 CFR 874.1325 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KLX is the FDA product code for Electroglottograph, a class II device type, regulated under 21 CFR 874.1325. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KLX
Device name
Electroglottograph
Regulation
21 CFR 874.1325
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
4
Ingested recalls
0

Clearances, product code KLX

By decision year
4 clearances under product code KLX with a decision year between 1982 and 1999, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KLX by decision year
YearClearances
19821
19841
19901
19991

Applicants with the most clearances

Product code KLX
Applicants holding the most 510(k) clearances under product code KLX
ApplicantClearances
Glottal Ent., Inc.1
Kay Elemetrics Corp.1
Ms. Kate Teaney1
Teltec Electronic Equipment AB1

Companies listing this code with FDA

Companies whose registered establishments list this code