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

    CPROTECTOR

    K Number: K934821 · Decision Jan 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    102
    Applicant Total
    17
    Review Days
    90

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    Basic Information

    Device Name
    CPROTECTOR
    K Number
    K934821
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5870
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Certified Safety Mfg., Inc.
    Date Received
    October 8, 1993
    Decision Date
    January 6, 1994
    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.

    K Number Device Name
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    K953102 BLOODBORNE PATHOGEN KIT
    K946338 CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING
    K945004 2, 3 & 4 BANDADGE COMPRESS
    K945002 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE
    K940249 CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING
    K941311 FIRST AID/TRUMA KIT
    K940358 X-LARGE MULTI-FUNCTION TRAUMA DRESSING
    Search all 17 clearances from Certified Safety Mfg., Inc. →