BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SEAC MOBILE UNIT BY ASI MEDICAL

    K Number: K932873 · Decision Mar 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    283
    Applicant Total
    5
    Review Days
    266

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    Basic Information

    Device Name
    SEAC MOBILE UNIT BY ASI MEDICAL
    K Number
    K932873
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Asi Medical, Inc.
    Date Received
    June 14, 1993
    Decision Date
    March 7, 1994
    Product Code
    EIA
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EIA Unit, Operative Dental

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    Other Clearances by Asi Medical, Inc.

    K Number Device Name
    K123139 ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES
    K110481 TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
    K974488 AIRPREP SYSTEM - MODEL 9001
    K974487 SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020