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

Colonoscope And Accessories, Flexible/Rigid (FDF) (3) Electroglottograph (KLX) (3) Gastroscope And Accessories, Flexible/Rigid (FDS) (2) Device, Digital Image Storage, Radiological (LMB) (1) Endoscope, Accessories, Image Post-Processing For Color Enhancement (PEA) (1)

Premarket Exempt

No Yes

Clear

VIDEO COLONOSCOPE - 04961333244560 Catalog Number :

Device Description : VIDEO COLONOSCOPE - PTAH (USED)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : FDF

Prescription Use : Yes

Device Count : 1

VIDEO COLONOSCOPE - 04961333244577 Catalog Number :

Device Description : VIDEO COLONOSCOPE - PTAH (USED)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : FDF

Prescription Use : Yes

Device Count : 1

VIDEO GASTROSCOPE - 04961333244584 Catalog Number :

Device Description : VIDEO GASTROSCOPE - PTAH (USED)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : FDS

Prescription Use : Yes

Device Count : 1

VIDEO GASTROSCOPE - 04961333244591 Catalog Number :

Device Description : VIDEO GASTROSCOPE - PTAH (USED)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : FDS

Prescription Use : Yes

Device Count : 1

VIDEO PROCESSOR - 04961333244607 Catalog Number :

Device Description : VIDEO PROCESSOR - PTAH (VERSA) (USED)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : PEA

Prescription Use : Yes

Device Count : 1

DELL - 04961333244614 Catalog Number :

Device Description : DELL HOT PLUG HARD DRIVE 1.2 TB

Device Class : 1

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : LMB

Prescription Use : Yes

Device Count : 1

VISI-PITCH - 04961333244621 Catalog Number :

Device Description : VISI-PITCH IV (JAPAN)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

NASOMETER II - 04961333244638 Catalog Number :

Device Description : COMPUTERIZED SPEECH LAB (JAPAN)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

PHONATORY AERODYNAMIC SYSTEM - 04961333244645 Catalog Number :

Device Description : NASOMETER II (JAPAN)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

VIDEO COLONOSCOPE - 04961333244652 Catalog Number :

Device Description : VIDEO COLONOSCOPE - PTAH

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : FDF

Prescription Use : Yes

Device Count : 1

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