MICRO AUDIOMETRICS CORPORATION

Address:1901 Mason Ave,Daytona Beach,FL,32117,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)

Premarket Exempt

Yes

Clear

Earscan 3 - 00862185000301 Catalog Number : 06.001

Device Description : Earscan 3 Manual Audiometer.

Device Class : 2

Duns Number: 048573265

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

Earscan 3 - 00862185000318 Catalog Number : 04.001

Device Description : Earscan 3 Screening Audiometer.

Device Class : 2

Duns Number: 048573265

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

Earscan 3 - 00862185000325 Catalog Number : 05.001

Device Description : Earscan 3 Automatic Threshold Audiometer.

Device Class : 2

Duns Number: 048573265

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

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