FDA.reportPublic FDA data

N/A

Primary DI
04961333229987
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
5167B
Device description
Games, Software
Published
2017-04-06
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
04961333229987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333229987049613332299874961333229987

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
083211284
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854924006255C2 CryoBalloon Ablation System FG-10252025-04-04
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333232550ULTRASOUND GASTROSCOPEEG-3670URK2017-04-06
04961333232567ULTRASOUND GASTROSCOPEEG-3870UTK2017-04-06
04961333233953ULTRASOUND GASTROSCOPEEG-3270UK2017-06-26
04961333231942VIDEO PROCESSOREPK-I5010-US2018-04-16
04961333232598VIDEO PROCESSOREPK-I50102017-04-06
04961333232604VIDEO PROCESSOREPK-I70102017-04-06
04961333242207N/A92026/102018-03-08
04961333242214N/A92026/252018-03-08
04961333242221N/A92026/32018-03-08
04961333242238N/A92026/502018-03-08
04961333242276N/A92052/202018-03-08
04961333242283N/A92052/62018-03-08
04961333242306N/A92092/122018-03-08
04961333242313N/A92092/252018-03-08

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