BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CPROTECTOR 2000

    K Number: K960587 · Decision Jul 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    102
    Applicant Total
    17
    Review Days
    525

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    Basic Information

    Device Name
    CPROTECTOR 2000
    K Number
    K960587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5870
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Certified Safety Mfg., Inc.
    Date Received
    February 12, 1996
    Decision Date
    July 21, 1997
    Product Code
    CBP
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CBP Valve, Non-Rebreathing

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    Other Clearances by Certified Safety Mfg., Inc.

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    K945004 2, 3 & 4 BANDADGE COMPRESS
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    K940249 CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING
    K941311 FIRST AID/TRUMA KIT
    K940358 X-LARGE MULTI-FUNCTION TRAUMA DRESSING
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