Examinetics, Inc.

Address:10561 Barkley Street,Overland Park,KS,66212,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

Salux™ - 00860007826603 Catalog Number : SALUX-AU-01

Device Description : Bluetooth audiometer portion of Salux™ Tablet-Controlled Audiometer. The Examin Bluetooth audiometer portion of Salux™ Tablet-Controlled Audiometer. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.

Device Class : 2

Duns Number: 147251958

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

Salux™ - 00860007826610 Catalog Number : SALUX-HP-01

Device Description : Headphone portion for Salux™ Tablet-Controlled Audiometer. The Examinetics Tabl Headphone portion for Salux™ Tablet-Controlled Audiometer. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.

Device Class : 2

Duns Number: 147251958

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

Salux™ - 00860007826627 Catalog Number : SALUX-SW-01

Device Description : iOS application portion for Salux™ Tablet-Controlled Audiometer system. The Exam iOS application portion for Salux™ Tablet-Controlled Audiometer system. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.

Device Class : 2

Duns Number: 147251958

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

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