PENTAX OF AMERICA, INC.

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) (6) Colonoscope And Accessories, Flexible/Rigid (FDF) (1) Endoscope, Accessories, Image Post-Processing For Color Enhancement (PEA) (1) Endoscopic Irrigation/Suction System (OCX) (1) Endoscopic Video Imaging System/Component, Gastroenterology-Urology (FET) (1)

Premarket Exempt

No Yes

Clear

C2 CryoBalloon EndoGrip - 00854924006408 Catalog Number :

Device Description : EndoGrip

Device Class : 2

Duns Number: 083211284

Premarket Exempt : No

Product Code : OCX

Prescription Use : Yes

Device Count : 1

DEFINA - 04961333225262 Catalog Number :

Device Description : DEFINA HD VIDEO PROCESSOR (US NEW)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : No

Product Code : PEA

Prescription Use : Yes

Device Count : 1

VIDEO COLONOSCOPE - 04961333225613 Catalog Number :

Device Description : VIDEO COLONOSCOPE

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : FDF

Prescription Use : Yes

Device Count : 1

VIDEO PROCESSOR - 04961333228928 Catalog Number :

Device Description : EPK-1000 VIDEO PROCESSOR (US NEW)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : No

Product Code : FET

Prescription Use : Yes

Device Count : 1

N/A - 04961333229628 Catalog Number : N/A

Device Description : Auditory Feedback Tools, Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

SONA-SPEECH II - 04961333229635 Catalog Number : N/A

Device Description : Sona-Speech II

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

MULTI-SPEECH - 04961333229642 Catalog Number :

Device Description : Multi-Speech Software

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

MULTI-SPEECH - 04961333229659 Catalog Number :

Device Description : Multi-Speech Microphone Preamp

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229666 Catalog Number :

Device Description : Microphone, Headset Condensor Type

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

VRP - 04961333229673 Catalog Number :

Device Description : Voice Range Profile S/W Program (VRP)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

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