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

    MODIFIED REFLUX REDUCER

    K Number: K883818 · Decision Nov 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    26
    Applicant Total
    8
    Review Days
    74

    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
    MODIFIED REFLUX REDUCER
    K Number
    K883818
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5140
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Physician Engineered Products, Inc.
    Date Received
    September 8, 1988
    Decision Date
    November 21, 1988
    Product Code
    FMS
    Advisory Committee
    General Hospital
    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
    FMS Bed, Pediatric Open Hospital

    Similar 510(k) Clearances

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

    NATURE'S CRADLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VAIL 100 PEDIATRIC CRIB

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NATURE'S CRADLE MODEL C1500

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STRYKER ADEL BASSINET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NATURE'S CRADLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, B

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Physician Engineered Products, Inc.

    K Number Device Name
    K110550 BRIGHT EMBRACE MODEL SBL60
    K093618 BILI-MIRROR MODEL BLM-1
    K974830 ULTRA BILI LIGHT
    K882291 RETROFIT BABY FACE SHIELD (RFS)
    K882278 RESUSCITATION BAG CONTROLLER (RBC)
    K873700 INSTITUTIONAL BILI LIGHT (IBL)
    K850599 HOME BILI LIGHTS-MODEL 100