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    FDA 510(k), K903654, LISS CRANIAL STIMULATOR MODEL SBL202-B

    FDA 510(k), K903654, LISS CRANIAL STIMULATOR MODEL SBL202-B

    $89.00 USD
    $89.00 USD
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    510(K) Number: K903654
    Device Name: LISS CRANIAL STIMULATOR MODEL SBL202-B
    Manufacturer:
    Device Classification Name: Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
    Regulation Number: 882.5800
    Classification Product Code: QJQ
    Date Received: 07/06/1990
    Decision Date: 10/04/1990
    Regulation Medical Specialty: Neurology

    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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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