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

    INCUBATOR CAPE

    K Number: K040794 · Decision Jun 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    14
    Applicant Total
    2
    Review Days
    73

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    INCUBATOR CAPE
    K Number
    K040794
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wrapped IN Comfort
    Date Received
    March 29, 2004
    Decision Date
    June 10, 2004
    Product Code
    MMP
    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
    MMP Cover, Barrier, Protective

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MMP), ordered by most recent decision date.

    MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LIGHT DRAPE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDLINE BAND BAGS AND EQUIPMENT COVERS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDSURG EQUIPMENT COVERS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Wrapped IN Comfort

    K Number Device Name
    K043234 LIGHT DRAPE