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

    CLEM TM

    K Number: K902788 · Decision Sep 12, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    34
    Applicant Total
    15
    Review Days
    78

    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
    CLEM TM
    K Number
    K902788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Arbo Medical, Inc.
    Date Received
    June 26, 1990
    Decision Date
    September 12, 1990
    Product Code
    FIB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FIB Protector, Transducer, Dialysis

    Similar 510(k) Clearances

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

    NovaLine SP-C35 Transducer Protector (956007)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HEMODIALYSIS TUBING SETS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Arbo Medical, Inc.

    K Number Device Name
    K940323 ARBO DIAGNOSTIC ECG PATIENT CABLES & LEADWIRES ARBO SHIELDED MULTI-LEAD CABLE & LEAD SYSTEM
    K935437 ARBO H85V/H87V/H27V DISPOS MONIT ELECTRODES
    K942905 DISPOSABLE TEMPERATURE PROBE COVER
    K940302 ARBO MONITRING SAFETY CABLE & LEAD WIRE SYSTEMS/ARBO UNSHEILDED SAFETY CABLE & LEAD SYSTEM
    K940322 ARBO VS MONITOR CABLE & LEADWIRE SYSTEM ARBO SHIELDED SAFETY CABLE & LEAD WIRE
    K935246 ARBO H49P, H59P DISPOSABLE MONITORING ELECTRODES
    K935429 ARBO H90, H91, H135 DISPOSABLE MONITORING ELECTRODES
    K935281 ARBO H87P, H85P, H27P DISPOSABLE MONITORING ELECTRODES
    K905545 ULTRASOUND TRANSMISSION GEL
    K901816 PRESSURE TUBING AND ACCESSORIES
    Search all 15 clearances from Arbo Medical, Inc. →