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

    NOVAMETRIX PULSE OXIMETER, MODEL 500

    K Number: K853124 · Decision Nov 6, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    45
    Review Days
    104

    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
    NOVAMETRIX PULSE OXIMETER, MODEL 500
    K Number
    K853124
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2780
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Novametrix Medical Systems, Inc.
    Date Received
    July 25, 1985
    Decision Date
    November 6, 1985
    Product Code
    JOM
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

    Similar 510(k) Clearances

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

    PADnet Xpress

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MESI mTABLET TBI diagnostic system, MESI mTABLET TBI

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASI Plethysmogrpah Analyzer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Automated ankle brachial pressure index measuring device, MESI mTABLET system

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VitalScan ANS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Automated ankle brachial pressure index measuring device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Novametrix Medical Systems, Inc.

    K Number Device Name
    K010451 NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
    K000794 MODIFICATION TO MARSPO2, MODEL 2001
    K993979 MARSPO2, MODEL 2001
    K982499 COSMO PLUS WITH NICO, MODEL 8200
    K964360 VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
    K963380 CO 2 SMO PLUS
    K963327 TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
    K960831 VENTRAK RMMS 1550
    K924626 NOVAMETRIX MODEL 510
    K920379 NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
    Search all 45 clearances from Novametrix Medical Systems, Inc. →