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    FDA 510(k), K231820, SoloSmart Injection Pen Adapter (SoloSmart®)

    FDA 510(k), K231820, SoloSmart Injection Pen Adapter (SoloSmart®)

    $89.00 USD
    $89.00 USD
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    510(K) Number: K231820
    Device Name: SoloSmart Injection Pen Adapter (SoloSmart®)
    Manufacturer: Alexia Garin
    Device Classification Name: Injection Data Capture Device
    Regulation Number: QOG
    Classification Product Code: KXA
    Date Received: 06/21/2023
    Decision Date: 01/12/2024
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: General Hospital

    PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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