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

    MODEL #05 ANEROID SPHYGMOMANOMETER KIT

    K Number: K913814 · Decision Jan 16, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    4
    Review Days
    143

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    Basic Information

    Device Name
    MODEL #05 ANEROID SPHYGMOMANOMETER KIT
    K Number
    K913814
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    National Health-Care Equipment, Inc.
    Date Received
    August 26, 1991
    Decision Date
    January 16, 1992
    Product Code
    ELY
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ELY Mercury

    Similar 510(k) Clearances

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    DENTAL MERCURY

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    MERCURY DENTAL

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    FDA Class 2 ·Dental

    DENTAL-QUECKSILBER (DENTAL MERCURY)

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    FDA Class 2 ·Dental
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    Other Clearances by National Health-Care Equipment, Inc.

    K Number Device Name
    K913880 INFRARED HEAT LAMP MODEL NH-202
    K913856 INFRARED HEAT LAMP MODEL NH-201
    K913973 INFRARED HEAT LAMPS & MASSAGER MODEL NH-213