BEUDAMED
    3 results · 78ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.

    FDA Recall
    Terminated ·Tobii Assistive Technology, Inc.·Product code ILQ·January 14, 2013

    Tobii C-Series Lithium batteries Type TB8A, TB8B, TB12A used with the Tobii C8 and Tobii C12 Speech Generating Communication Devices. Communication device for the impaired and functions as a speech generating device; text or symbols can be used to generate synthesized or digitized speech. Perfect for asking or answering questions, having a conversation.

    FDA Recall
    Terminated ·Tobii Assistive Technology, Inc.·Product code ILQ·May 31, 2011

    P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.

    FDA Enforcement
    Class II ·Terminated·Tobii Assistive Technology, Inc.·February 13, 2013