Ototronix, LLC

Address:3727 Greenbriar Drive, Suite 203,Stafford,TX,77477,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

Audiometer (EWO) (3) Cement, Ear, Nose And Throat (NEA) (2)

Premarket Exempt

Clear

PROCEM - M737P97301 Catalog Number :

Device Description : Procem Applicator

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : NEA

Prescription Use : No

Device Count : 1

PROCEM - M737P97401 Catalog Number :

Device Description : Procem Activator

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : NEA

Prescription Use : No

Device Count : 1

Otogram - M737S3000R1 Catalog Number :

Device Description : Otogram S3000R

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Otogram - M737S50001 Catalog Number :

Device Description : Otogram S5000

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Otogram - M737S55001 Catalog Number :

Device Description : Otogram S5500

Device Class : 2

Duns Number: 833067478

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

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