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

    COLLAR, CERVICAL, SPLIT

    K Number: K780136 · Decision Jan 31, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    297
    Registration Numbers
    297
    Same Product Code
    26
    Applicant Total
    48
    Review Days
    6

    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
    COLLAR, CERVICAL, SPLIT
    K Number
    K780136
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3490
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Richard'S Medical Equip., Inc.
    Date Received
    January 25, 1978
    Decision Date
    January 31, 1978
    Product Code
    IQK
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IQK Orthosis, Cervical

    Similar 510(k) Clearances

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

    DORMIE NECK SUPPORT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SCHUL-TEC IMMOBILIZER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    MEDICAL DISPOSABLE BEDDING

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    NOVA PILLOW

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BATTLE CREEK PILLOW

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CERVICAL COLLARS & HEAD HALTERS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all

    Other Clearances by Richard'S Medical Equip., Inc.

    K Number Device Name
    K830793 PATIENT GUIDED ELBOW & SHOULDER EXERC
    K823837 RMC TOTAL KNEE SYSTEM
    K823726 SPECTRON CONVERSION ENDOPROSTHESIS CUP
    K823724 SPECTRON NECK REPLACEMENT PROSTHESIS
    K823723 SPECTRON PROXIMAL FEMORAL PROSTHESIS
    K823722 SPECTRON LONG, STRAIGHT FEMORAL PROSTHES
    K823727 SPECTRON PRIMARY STEM FEMORAL PROSTHES
    K830153 RICHARDS INTRA-ARTICULAR SHAVER BLADES
    K830154 COLLES FRACTURE FRAME
    K823725 SPECTRON PROTRUSIO CUP
    Search all 48 clearances from Richard'S Medical Equip., Inc. →