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ESE — Larynx, Artificial (Battery-Powered) Class I

FDA Device Classification

Classification Details

Product Code
ESE
Device Class
Class I
Regulation Number
874.3375
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K934483mountain precision mfg. ltdNU-VOIS BATTERY POWERED ARTIFICIAL LARYNXMarch 16, 1994
K931371denrickDENRICK SPEECH AID (DR-1)August 25, 1993
K923648bruce medical supplyLECTRO-LARYNXApril 7, 1993
K914816ultravoiceAMERICAN ARTIFICIAL LARYNXFebruary 12, 1993
K901503stanton magneticsADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEMJune 28, 1990
K860992bloomfield research and developmentVOX COMPANIONMay 2, 1986
K860993bloomfield research and developmentP.O. VOXApril 25, 1986
K854158dynamed audioRESNICK EMITTER, ARTIFICIAL LARYNXDecember 13, 1985
K840892cisko systemsELECTRO-PALATEMay 22, 1984
K834555bear medical systemsBEAR VENTI--VOICEJanuary 24, 1984
K834522respiratory support productsVENTI-VOICE NASAL CATHETERJanuary 17, 1984
K831127xomedINTRA-ORAL ARTIFICIAL LARYNXJuly 28, 1983
K823118kells medicalSAYJanuary 7, 1983