BENSON MEDICAL INSTRUMENTS COMPANY

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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) (5) Spirometer, Diagnostic (BZG) (3)

Premarket Exempt

No Yes

Clear

NA - B2075002960 Catalog Number : NA

Device Description : AUDIOMETER

Device Class : 2

Duns Number: 957930696

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

NA - B2075003030 Catalog Number : NA

Device Description : AUDIOMETER

Device Class : 2

Duns Number: 957930696

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

NA - B2075003070 Catalog Number : NA

Device Description : AUDIOMETER

Device Class : 2

Duns Number: 957930696

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

NA - B2075003220 Catalog Number : NA

Device Description : AUDIOMETER

Device Class : 2

Duns Number: 957930696

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

NA - B207500326100 Catalog Number : 500326-100

Device Description : U-tube Mouthpieces

Device Class :

Duns Number: 957930696

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 100

NA - B2075003470 Catalog Number : NA

Device Description : SPIROMETER

Device Class : 2

Duns Number: 957930696

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 1

NA - B207500434100 Catalog Number : NA

Device Description : U-tube Mouthpieces

Device Class :

Duns Number: 957930696

Premarket Exempt : No

Product Code : BZG

Prescription Use : No

Device Count : 100

Benson Medical Instruments Co. - B2075004420 Catalog Number : NA

Device Description : Fit Test Audiometer

Device Class : 2

Duns Number: 957930696

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

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