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) Monitor, Esophageal Motility, And Tube (KLA) (4)

Premarket Exempt

No Yes

Clear

ELECTROGLOTTOGRAPH - 04961333229888 Catalog Number :

Device Description : KayPentax Electroglottograph

Device Class : 2

Duns Number: 083211284

Premarket Exempt : No

Product Code : KLX

Prescription Use : Yes

Device Count : 1

NASOMETER II - 04961333229895 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 - 04961333229901 Catalog Number :

Device Description : Phonatory Aerodynamic System

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

PHONATORY AERODYNAMIC SYSTEM - 04961333229918 Catalog Number :

Device Description : PAS Tubes, Intraoral

Device Class :

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 50

N/A - 04961333229925 Catalog Number :

Device Description : EMG Transducers (two channel)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

N/A - 04961333229932 Catalog Number :

Device Description : Manometry Sensors (Gaeltec)

Device Class : 2

Duns Number: 083211284

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

N/A - 04961333229949 Catalog Number :

Device Description : Nasal Cannulas

Device Class :

Duns Number: 083211284

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 50

N/A - 04961333229956 Catalog Number :

Device Description : Laryngeal Microphone

Device Class : 2

Duns Number: 083211284

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

VISI-PITCH IV - 04961333229963 Catalog Number :

Device Description : Visi-Pitch IV

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

N/A - 04961333229970 Catalog Number :

Device Description : Computerized Speech Lab, H/W & S/W

Device Class : 2

Duns Number: 083211284

Premarket Exempt : Yes

Product Code : KLX

Prescription Use : Yes

Device Count : 1

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