PENTAX OF AMERICA, INC.

Address:3 Paragon Drive,MONTVALE,NJ,07645,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electroglottograph (KLX) (10)

Premarket Exempt

No Yes

Clear

N/A - 04961333229680 Catalog Number :

Device Description : Phonetic Database Program, Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229697 Catalog Number :

Device Description : Palatometer Database Program, Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229703 Catalog Number :

Device Description : Disordered Voice Database & Program

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229710 Catalog Number :

Device Description : Microphone Accessory Kit

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229727 Catalog Number :

Device Description : Computerized Speech Lab

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

ASL - 04961333229734 Catalog Number :

Device Description : Analysis-Synthesis Laboratory (ASL) Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

MDVP - 04961333229741 Catalog Number :

Device Description : Multi-Dimensional Voice Program (MDVP) Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

ADSV - 04961333229758 Catalog Number :

Device Description : Analysis of Dysphonia in Speech and Voice (ADSV™)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

REAL-TIME - 04961333229765 Catalog Number :

Device Description : Real-Time Pitch Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

SONA-MATCH - 04961333229772 Catalog Number :

Device Description : Sona-Match, Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

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