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 - 04961333229987 Catalog Number :

Device Description : Games, Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

MULTI-SPEECH - 04961333230006 Catalog Number :

Device Description : Multi-Speech Microphone, Condensor

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

MULTI-SPEECH - 04961333230013 Catalog Number :

Device Description : Multi-Speech Microphone, Dynamic

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

MULTI-SPEECH - 04961333230020 Catalog Number :

Device Description : Multi-Speech USB Sound Recorder & Preamp

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333230037 Catalog Number :

Device Description : Computer for Mult-Speech or CSL

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333230044 Catalog Number :

Device Description : Signal Enhancement Program, Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333230051 Catalog Number :

Device Description : Educational Bundle, Speech Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333230068 Catalog Number :

Device Description : Speech Products Master Upgrade

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

PHONATORY AERODYNAMIC SYSTEM - 04961333230075 Catalog Number :

Device Description : PAS Airflow Head

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

PHONATORY AERODYNAMIC SYSTEM - 04961333230082 Catalog Number :

Device Description : PAS Mask and Adapter (Reusable)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

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