FDA.reportPublic FDA data

Two Channel Electroglottograph EG2-PCX2

Primary DI
00860011116905
Brand
Two Channel Electroglottograph EG2-PCX2
Company
Glottal Enterprises, Inc.
Model
EG2-PCX2
Device description
Device for the non-invasive measurement of vocal fold contact area.
Published
2024-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KLXElectroglottograph

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901609000ELECTROGLOTTOGRAPHGlottal Ent., Inc.1990-06-28KLX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011116905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011116905008600111169058600111169050860011116905

GMDN Terms#

Term, Definition table
TermDefinition
ElectroglottographA graphic recorder designed for recording the changes in electrical potential or impedance, using a sensor, resulting from movement of the vocal cords during respiration and phonation. It is intended to be used to asses the degree of closure of the vocal cords during treatment of voice disorders and in the study of the laryngeal mechanism.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
114191554
Device count
1
Serial number
true

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
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
04961333230068N/APENTAX OF AMERICA, INC.KLX2017-04-07