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

REAL-TIME - 04961333229789 Catalog Number :

Device Description : Real-Time Spectrogram Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

REAL-TIME - 04961333229796 Catalog Number :

Device Description : Real-Time EGG Analysis Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : No

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229802 Catalog Number :

Device Description : Motor Speech Products, Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229819 Catalog Number :

Device Description : Video Phonetics Program & Database

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229826 Catalog Number :

Device Description : Phonetic & Perception Simulation Program, Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229833 Catalog Number :

Device Description : Respiration, Phonation and Prosody Simulation, Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229840 Catalog Number :

Device Description : Applied Speech Science for Dysarthrias, Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229857 Catalog Number :

Device Description : Speech Articulation: Animation of Muscle Vectors, Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229864 Catalog Number :

Device Description : Nueroscience for Human Communication, Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229871 Catalog Number :

Device Description : Applied Speech Science for Voice & Resonance Disorders, Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

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