BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇮 Finland

    SATLITE PLUS PULSE OXIMETER

    K Number: K905140 · Decision May 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    55
    Review Days
    194

    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
    SATLITE PLUS PULSE OXIMETER
    K Number
    K905140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Datex Division Instrumentarium Corp.
    Date Received
    November 15, 1990
    Decision Date
    May 28, 1991
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    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
    DQA Oximeter

    Similar 510(k) Clearances

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

    Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AViTA Pulse Oximeter (SP61)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)

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

    Other Clearances by Datex Division Instrumentarium Corp.

    K Number Device Name
    K953175 AS/3 ESTPR MODULE
    K961247 AS/3 LIGHT MONITOR
    K943458 AS/3 AIRWAY MODULE
    K945234 AS/3 MEMORY MODULE, M0MEM
    K933156 DATEX AS/3 PATIENT MONITOR
    K933285 DATEX AS/3 TM ANAESTHESIA MONITOR
    K943456 AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT
    K923172 ANAESTHESIA RECORD KEEPER
    K935477 AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD
    K943457 AS/3 PRESSURE TEMPERATURE MODULE, M-PT
    Search all 55 clearances from Datex Division Instrumentarium Corp. →