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

    MODIFIED MYOCARDIAL TEMPERATURE SENSOR

    K Number: K874522 · Decision Jan 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    36
    Applicant Total
    17
    Review Days
    88

    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
    MODIFIED MYOCARDIAL TEMPERATURE SENSOR
    K Number
    K874522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1915
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Mon-A-Therm, Inc.
    Date Received
    November 2, 1987
    Decision Date
    January 29, 1988
    Product Code
    KRB
    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
    KRB Probe, Thermodilution

    Similar 510(k) Clearances

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

    PiCCO Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV 4046

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT

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

    Other Clearances by Mon-A-Therm, Inc.

    K Number Device Name
    K885187 MODEL 1000 ELECTRONIC CLINICAL THERMOMETER
    K874519 MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR
    K875234 MON-A-THERM'S SKIN TEMPERATURE SENSOR
    K874525 MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR
    K874524 MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR
    K874523 MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR
    K874521 MODIFIED THERMAL WELL TEMPERATURE SENSOR
    K874520 MODIFIED AIRWAY TEMPERATURE SENSOR
    K853392 MON-A-THERM SUBCUTANEOUS TEMP. SENSOR
    K830819 MODIFICATION ELECTRONIC CLINICAL THERMO-
    Search all 17 clearances from Mon-A-Therm, Inc. →