BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    KEYMED FIBERSCOPE AUTO DISINFECTOR

    K Number: K861821 · Decision Feb 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    11
    Applicant Total
    29
    Review Days
    276

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    Basic Information

    Device Name
    KEYMED FIBERSCOPE AUTO DISINFECTOR
    K Number
    K861821
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Keymed, Inc.
    Date Received
    May 12, 1986
    Decision Date
    February 12, 1987
    Product Code
    NVE
    Advisory Committee
    Gastroenterology, Urology
    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
    NVE Washer, Cleaner, Automated, Endoscope

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    Other Clearances by Keymed, Inc.

    K Number Device Name
    K100803 OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
    K921179 OLYMPUS-KEYMED DISINFECTANT FUME EXTRACTOR DFE-20
    K881004 OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR
    K864801 THE KEYMED HI-LIGHT 250 LIGHT SOURCE
    K862000 KEYMED FLEXIBLE ESOPHAGEAL DILATORS
    K860528 THE KEYMED FIBERSCOPE STERILIZATION CASE
    K861147 UCS-2, ULTRASONIC CLEANING SOLUTION
    K860704 THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND
    K851149 KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1
    K854304 KEYMED OFFICE COUCH
    Search all 29 clearances from Keymed, Inc. →