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  • 1.  ISD code

    Posted 29-Oct-2022 07:27
    Hi community!

    Does enyone knows or knows where I can find information about when the ISD porduct code was added to the list of exempt 510k codes? 

    Best regards


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    Ana Clemente
    Portela
    Portugal
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  • 2.  RE: ISD code

    Posted 30-Oct-2022 08:40
    The ISD Product Code was amended at 84 FR 71818, Dec. 30, 2019 and again at final at 85 FR 44188, July 22, 2020.

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    Lee Leichter RAC
    President
    Fort Denaud FL
    United States
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    Original Message


  • 3.  RE: ISD code

    Posted 30-Oct-2022 08:41
    Sorry, You can look up the Federal Register Notices on the FDA search website

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    Lee Leichter RAC
    President
    Fort Denaud FL
    United States
    ------------------------------

    Original Message


  • 4.  RE: ISD code

    Posted 30-Oct-2022 09:11
    Thanks a lot.

    Can be this?

    Medical Devices; Exemptions From Premarket Notification: Class II Devices
    Federal Register remove preview
    Medical Devices; Exemptions From Premarket Notification: Class II Devices
    The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is...
    View this on Federal Register >


    Best

    ------------------------------
    Ana Clemente
    Portela
    Portugal
    ------------------------------

    Original Message


  • 5.  RE: ISD code

    Posted 30-Oct-2022 09:22

    Yes, that would be one of the notices

     




    Original Message


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