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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: C-Eye; ECO Point; I-12; I-15; PCEye; PCEye Go; S32; Tobii C12; Tobii C15; Tobii C8; Tobii Communicator
Classification Name: SYSTEM, COMMUNICATION, POWERED
Product Code: ILQ
Device Class: 2
Regulation Number: 890.3710
Medical Specialty: Physical Medicine
Registered Establishment Name: TOBII TECHNOLOGY AB
Registered Establishment Number: 3005301283
Owner/Operator: TOBII ASSISTIVE TECHNOLOGY INC
Owner/Operator Number: 9076359
Establishment Operations: Manufacturer; Specification Developer; Complaint File Establishment
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