FDA.reportPublic FDA data

N/A

Primary DI
04961333229666
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
4302
Device description
Microphone, Headset Condensor Type
Published
2017-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KLXElectroglottograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLXElectroglottographEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333229666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333229666049613332296664961333229666

GMDN Terms#

Term, Definition table
TermDefinition
Voice amplification systemAn assembly of battery-powered, personal-worn, devices designed to amplify the loudness of the voice of a person with reduced vocal capacity (e.g., due to impairment of throat or chest muscles, partial paralysis of vocal cords, diminished lung capacity). It typically includes a dedicated microphone, an electronic amplifier, and a loudspeaker. Assemblies with special adaptors that are intended for use with an artificial larynx, a transoesophageal puncture tube, and/or other prostheses or implants are available. Some amplifiers are available as an integral part of an artificial larynx.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333225262DEFINAEPK-3000-US2018-04-16
04961333230594N/A9122D2017-04-06
04961333232154VIDEO BRONCHOSCOPEEB-1170K2017-04-06
04961333232161VIDEO BRONCHOSCOPEEB-1570K2017-04-06
04961333232178VIDEO BRONCHOSCOPEEB-1575K2017-04-06
04961333232185VIDEO BRONCHOSCOPEEB-1970K2017-04-06
04961333232192VIDEO BRONCHOSCOPEEB-1970TK2017-04-06
04961333232208ULTRASOUND BRONCHOSCOPEEB-1970UK2017-04-06
04961333232215VIDEO BRONCHOSCOPEEB-1975K2017-04-06
04961333232222VIDEO BRONCHOSCOPEEB-1990I2017-04-06
04961333232239VIDEO COLONOSCOPEEC-2990LI2017-04-06
04961333232253VIDEO COLONOSCOPEEC-3490LI2017-04-06
04961333232260VIDEO COLONOSCOPEEC-3490LK2017-04-06
04961333232277VIDEO COLONOSCOPEEC-3490TLI2017-04-06
04961333232284VIDEO COLONOSCOPEEC34-I10L2017-04-06
04961333232345VIDEO COLONOSCOPEEC-3890LI2017-04-06
04961333232352VIDEO COLONOSCOPEEC-3890LK2017-04-06
04961333232369VIDEO COLONOSCOPEEC-3890LZI2017-04-06
04961333232376VIDEO COLONOSCOPEEC-3890TLK2017-04-06
04961333232383VIDEO COLONOSCOPEEC38-I10L2017-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04961333255979 MICROPHONE ASSAY KITPENTAX OF AMERICA, INC.KLX2025-07-21
04961333255986Disposables KitPENTAX OF AMERICA, INC.KLX2025-07-21
00860011116905Two Channel Electroglottograph EG2-PCX2Glottal Enterprises, Inc.KLX2024-07-01
04961333254309MULTI-SPEECHPENTAX OF AMERICA, INC.KLX2023-08-25
04961333247301NASOMETERPENTAX OF AMERICA, INC.KLX2019-06-07
04961333247318NASOMETERPENTAX OF AMERICA, INC.KLX2019-06-07
04961333247417PHONATORY AERODYNAMIC SYSTEM (SOFTWARE)PENTAX OF AMERICA, INC.KLX2019-06-07
04961333247424PHONATORY AERODYNAMIC SYSTEMPENTAX OF AMERICA, INC.KLX2019-06-07
04961333245390VISI-PITCHPENTAX OF AMERICA, INC.KLX2018-07-05
04961333245406N/APENTAX OF AMERICA, INC.KLX2018-07-05
04961333245413NASOMETER IIPENTAX OF AMERICA, INC.KLX2018-07-05
04961333245420PHONATORY AERODYNAMIC SYSTEMPENTAX OF AMERICA, INC.KLX2018-07-05
04961333244621VISI-PITCHPENTAX OF AMERICA, INC.KLX2018-03-26
04961333244638NASOMETER IIPENTAX OF AMERICA, INC.KLX2018-03-26
04961333244645PHONATORY AERODYNAMIC SYSTEMPENTAX OF AMERICA, INC.KLX2018-03-26
04961333241965N/APENTAX OF AMERICA, INC.KLX2018-03-06
04961333240487N/APENTAX OF AMERICA, INC.KLX2018-02-26
04961333236558NASOMETER IIPENTAX OF AMERICA, INC.KLX2017-11-14
04961333236565PHONATORY AERODYNAMIC SYSTEMPENTAX OF AMERICA, INC.KLX2017-11-14
04961333236572VISI-PITCHPENTAX OF AMERICA, INC.KLX2017-11-14
04961333236589N/APENTAX OF AMERICA, INC.KLX2017-11-14
04961333236718N/APENTAX OF AMERICA, INC.KLX2017-11-09
04961333235421CAPE VPENTAX OF AMERICA, INC.KLX2017-09-05
04961333235438VISI-PITCHPENTAX OF AMERICA, INC.KLX2017-09-05
04961333235445N/APENTAX OF AMERICA, INC.KLX2017-09-05
04961333229864N/APENTAX OF AMERICA, INC.KLX2017-04-07
04961333230020MULTI-SPEECHPENTAX OF AMERICA, INC.KLX2017-04-07
04961333230037N/APENTAX OF AMERICA, INC.KLX2017-04-07
04961333230044N/APENTAX OF AMERICA, INC.KLX2017-04-07
04961333230051N/APENTAX OF AMERICA, INC.KLX2017-04-07