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

    SPIROVISION

    K Number: K864885 · Decision Jan 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    25
    Applicant Total
    17
    Review Days
    34

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    Basic Information

    Device Name
    SPIROVISION
    K Number
    K864885
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1900
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Futuremed Div. of Future Impex Corp.
    Date Received
    December 12, 1986
    Decision Date
    January 15, 1987
    Product Code
    BZM
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZM Calculator, Pulmonary Function Interpretor (Diagnostic)

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    Other Clearances by Futuremed Div. of Future Impex Corp.

    K Number Device Name
    K933511 UPGRADED SPIROMETER ST-90
    K933220 SELECTOR SL 01
    K933222 AUDIOMETER DA 323
    K903017 MEGA-TENS DUAL CHANNEL T.E.N.S.
    K901308 SPIRO ANALYZER MODEL ST 250
    K884972 TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR
    K871421 MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT
    K873817 SPIRO ANALYZER ST-300
    K872044 CARBON ELECTRODE
    K871913 CONDUCTIVITY GEL
    Search all 17 clearances from Futuremed Div. of Future Impex Corp. →