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510(k) Data Aggregation

    K Number
    K982754
    Device Name
    EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)
    Manufacturer
    A. STEIN - REGULATORY AFFAIRS CONSULTING
    Date Cleared
    1999-01-08

    (155 days)

    Product Code
    FWF
    Regulation Number
    878.4160
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EC 1000-7 Digital Endoscopy Video Camera is a device used for monitoring and recording during endoscopic procedures.

    Device Description

    EC 1000-7 Digital Endoscopy Video Camera (Models EC 1000-7P (PAL) & EC 1000-7 (NTSC))

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the EC 1000-7 Digital Endoscopy Video Camera. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

    Therefore, I cannot provide the requested information. The text is a regulatory clearance and not a scientific or clinical study report.

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