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

    PCM 2000; ISOLAIR APR MODEL 2735

    K Number: K970448 · Decision Apr 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    224
    Registration Numbers
    224
    Same Product Code
    34
    Applicant Total
    21
    Review Days
    83

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    Basic Information

    Device Name
    PCM 2000; ISOLAIR APR MODEL 2735
    K Number
    K970448
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tecnol Medical Products, Inc.
    Date Received
    February 6, 1997
    Decision Date
    April 30, 1997
    Product Code
    MSH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MSH Respirator, Surgical

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    Other Clearances by Tecnol Medical Products, Inc.

    K Number Device Name
    K974068 PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
    K963559 WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)
    K963564 PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)
    K963552 QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)
    K963773 24457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT
    K963561 ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)
    K963563 ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)
    K963556 SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)
    K963554 24448-010 SECURE-ALL FINGER CONTROL MITT
    K963557 SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-030
    Search all 21 clearances from Tecnol Medical Products, Inc. →