FDA.reportPublic FDA data

MICROPHONE ASSAY KIT

Primary DI
04961333255979
Brand
MICROPHONE ASSAY KIT
Company
PENTAX OF AMERICA, INC.
Model
6651
Device description
6651 MICROPHONE ASSAY KIT(MU0P00001022)(Accessory for PAS 6600)
Published
2025-07-21
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333255979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333255979049613332559794961333255979

GMDN Terms#

Term, Definition table
TermDefinition
Speech assistive training deviceAn electronic device designed to assist a person with a disability in developing the use of voice and speech, particularly in relation to the production and awareness of sounds. Included are devices for training in spoken language, S-, F- and Sch-indicators and acoustic spectral analysers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
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
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
04961333230068N/APENTAX OF AMERICA, INC.KLX2017-04-07