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

    NCA-200

    K Number: K931608 · Decision Jun 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    6
    Applicant Total
    10
    Review Days
    82

    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
    NCA-200
    K Number
    K931608
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.1800
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ics Medical Corp.
    Date Received
    April 1, 1993
    Decision Date
    June 22, 1993
    Product Code
    KHH
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHH Stimulator, Caloric-Air

    Similar 510(k) Clearances

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

    HORTMANN AIRMATIC AIR CALORIC STIMULATOR

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    EAR-A-GATOR

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    WATER IRRIGATOR, W1 200

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    AUTOMATIC CALORIC IRRIGATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    AUTOMATIC CALORIC IRRIGATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    FRENZEL EYEGLASSES & RELATED ITEMS

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat
    View all

    Other Clearances by Ics Medical Corp.

    K Number Device Name
    K011181 ICS MEDICAL CHARTR OAE WITH TYMP
    K002985 ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS
    K991497 ICS MEDICAL CHARTR ENG/VNG DIAGNOSTIC SYSTEM
    K972631 ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER
    K960097 CHARTR EP
    K931609 CHARTR ENG SYSTEM
    K925237 AUTOMATIC CALORIC IRRIGATION SYSTEM
    K881630 AUTOMATIC CALORIC IRRIGATION SYSTEM
    K872093 RVT-50 ROTARY CHAIR FOR VESTIBULAR TESTING