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    FDA 510(k), K902954, OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)

    FDA 510(k), K902954, OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)

    $89.00 USD
    $89.00 USD
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    510(K) Number: K902954
    Device Name: OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)
    Manufacturer:
    Device Classification Name: Aspirator, Endocervical
    Regulation Number: 884.1050
    Classification Product Code: HFC
    Date Received: 07/05/1990
    Decision Date: 08/23/1990
    Regulation Medical Specialty: Obstetrics/Gynecology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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