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

    SPIRO ANALYZER MODEL ST 250

    K Number: K901308 · Decision Jul 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    227
    Applicant Total
    17
    Review Days
    125

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    Basic Information

    Device Name
    SPIRO ANALYZER MODEL ST 250
    K Number
    K901308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1840
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Futuremed Div. of Future Impex Corp.
    Date Received
    March 20, 1990
    Decision Date
    July 23, 1990
    Product Code
    BZG
    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
    BZG Spirometer, Diagnostic

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    Other Clearances by Futuremed Div. of Future Impex Corp.

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    K903017 MEGA-TENS DUAL CHANNEL T.E.N.S.
    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
    K872045 CONDUCTIVITY GEL
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