AMBCO ELECTRONICS

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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)

Premarket Exempt

Yes

Clear

AMBCO - 00851195007004 Catalog Number : 650A

Device Description : AMBCO Audiometer - Model 650A

Device Class : 2

Duns Number: 008322570

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

AMBCO - 00851195007011 Catalog Number : 650AB

Device Description : Audiometer - Model 650AB

Device Class : 2

Duns Number: 008322570

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

AMBCO - 00851195007028 Catalog Number : 1000+

Device Description : AMBCO Audiometer - Model 1000+

Device Class : 2

Duns Number: 008322570

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

AMBCO - 00851195007035 Catalog Number : 1000+P

Device Description : AMBCO Audiometer - Model 1000+P

Device Class : 2

Duns Number: 008322570

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

AMBCO - 00851195007042 Catalog Number : 2500

Device Description : AMBCO Audiometer - Model 2500

Device Class : 2

Duns Number: 008322570

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

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