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) (8) Medical Device Data System (OUG) (2)

Premarket Exempt

No Yes

Clear

N/A - 04961333245314 Catalog Number :

Device Description : MS SQL ENT - 8 CORE LIC (RUNTIME)

Device Class :

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 8

VISI-PITCH - 04961333245390 Catalog Number :

Device Description : v4.0 VISI-PITCH WIN10 UPGRADE

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333245406 Catalog Number :

Device Description : v4.0 CSL WIN10 UPGRADE

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

NASOMETER II - 04961333245413 Catalog Number :

Device Description : v4.0 NASOMETER WIN10 UPGRADE

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

PHONATORY AERODYNAMIC SYSTEM - 04961333245420 Catalog Number :

Device Description : v4.0 PAS WIN10 UPGRADE

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

NASOMETER - 04961333247301 Catalog Number :

Device Description : NASOMETER SOFTWARE

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

NASOMETER - 04961333247318 Catalog Number :

Device Description : NASOMETER

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

PHONATORY AERODYNAMIC SYSTEM (SOFTWARE) - 04961333247417 Catalog Number :

Device Description : PHONATORY AERODYNAMIC SYSTEM (SOFTWARE) CE

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

PHONATORY AERODYNAMIC SYSTEM - 04961333247424 Catalog Number :

Device Description : PHONATORY AERODYNAMIC SYSTEM CE

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

ENDOPRO REVIEW WORKSTATION - 04961333248001 Catalog Number : NA

Device Description : ENDOPRO REVIEW WORKSTATION

Device Class : 1

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : Yes

Device Count : 1

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