ATAIA INC.

Address:6751 Columbia Gateway Drive,Columbia,MD,21046,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

System, Communication, Powered (ILQ) (9)

Premarket Exempt

Yes

Clear

SPEAX Communicator - B792FGN001 Catalog Number : FGN001

Device Description : Communicator for use with the SPEAX Communication System

Device Class : 2

Duns Number: 117116534

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

SPEAX Patch - B792FGN002 Catalog Number : FGN002

Device Description : Patch for use with the SPEAX Communication System

Device Class :

Duns Number: 117116534

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

SPEAX Starter Package - B792FGN004 Catalog Number : FGN004

Device Description : The Starter Package for the SPEAX Communication System, including 5 Communicator The Starter Package for the SPEAX Communication System, including 5 Communicators and 30 Patches

Device Class : 2

Duns Number: 117116534

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

SPEAX Trial Package - B792FGN006 Catalog Number : FGN006

Device Description : The Trial Package for the SPEAX Communication System, including 1 Communicator a The Trial Package for the SPEAX Communication System, including 1 Communicator and 10 Patches

Device Class : 2

Duns Number: 117116534

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

SPEAX Digital Communicator - B792FGN007 Catalog Number : FGN007

Device Description : Digital Communicator for use with the SPEAX Communication System

Device Class : 2

Duns Number: 117116534

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

SPEAX Digital Communicator Trial Package - B792FGN008 Catalog Number : FGN008

Device Description : The Digital Communicator Trial Package for the SPEAX Communication System, inclu The Digital Communicator Trial Package for the SPEAX Communication System, including 1 Digital Communicator and 10 Patches.

Device Class : 2

Duns Number: 117116534

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

SPEAX Digital Communicator Subscription Package - B792FGN009 Catalog Number : FGN009

Device Description : The Digital Communicator Subscription Package for the SPEAX Communication System The Digital Communicator Subscription Package for the SPEAX Communication System, including 1 Digital Communicator and 20 Patches.

Device Class : 2

Duns Number: 117116534

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

SPEAX Patch for Home Use - B792FGN010 Catalog Number : FGN010

Device Description : Patch for use with the SPEAX Digital Communication System for Home Use

Device Class :

Duns Number: 117116534

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

SPEAX Digital Communication System for Home Use - B792FGN011 Catalog Number : FGN011

Device Description : SPEAX Digital Communication System for Home Use including Digital Communicator a SPEAX Digital Communication System for Home Use including Digital Communicator and Patches for Home Use

Device Class : 2

Duns Number: 117116534

Premarket Exempt : Yes

Product Code : ILQ

Prescription Use : Yes

Device Count : 1

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