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

    INTERTECH UNIVERSAL HYDROPHOBIC FILTER

    K Number: K890346 · Decision Mar 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    10
    Review Days
    37

    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
    INTERTECH UNIVERSAL HYDROPHOBIC FILTER
    K Number
    K890346
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Intertech/Ohio
    Date Received
    January 23, 1989
    Decision Date
    March 1, 1989
    Product Code
    CAH
    Advisory Committee
    Anesthesiology
    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
    CAH Filter, Bacterial, Breathing-Circuit

    Similar 510(k) Clearances

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

    Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Ambu® Virobac II® Exhalation Filter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Besmed Bacterial Filter and HMEF

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Breathing circuit bacterial/viral filter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TNI Clear-Guard™ 3 angled breathing filter (1545020)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by Intertech/Ohio

    K Number Device Name
    K895144 INTERTECH METERED DOSE ELBOW
    K884525 PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT
    K884526 ADULT RESUSCITATOR WITH MASK AND FILTER
    K882204 RESUSCITATOR VALVE ASSEMBLY W/FILTER
    K880394 FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR
    K863033 PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS
    K862020 HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER
    K860650 90 DEGREE ELBOW & STRAIGHT CONNECTOR
    K861056 STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG