BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CORE PREVENT MATTRESS MODIFICATION

    K Number: K935220 · Decision Nov 29, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    210
    Same Product Code
    13
    Applicant Total
    14
    Review Days
    48

    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
    CORE PREVENT MATTRESS MODIFICATION
    K Number
    K935220
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6190
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paladin Medical, Inc.
    Date Received
    October 12, 1993
    Decision Date
    November 29, 1993
    Product Code
    FMW
    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
    FMW Cover, Mattress (Medical Purposes)

    Similar 510(k) Clearances

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

    DermaTherapy Bed Linens

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DERMATHERAPY, MODEL 22216

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Z-NET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW

    FDA 510(k)
    FDA Class 1 ·General Hospital

    REUSABLE INCONTIENT UNDERPAD

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by Paladin Medical, Inc.

    K Number Device Name
    K993306 NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY)
    K970347 MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
    K971290 STRATASYS FDM MEDMODELER SYSTEM
    K964222 ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
    K950054 ENDO-BEND(TM) SHAVER
    K921015 SHARPE ENDOSPONGE ASPIIRATOR
    K915743 SHARPE ENDOTENACULUM
    K921888 SHARPE ENDODISSECTOR
    K915747 SHARPE ENDOFORCEPS
    K915744 SHARPE ENDOHEMOSTAT
    Search all 14 clearances from Paladin Medical, Inc. →