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

    TSX PRM PULMONARY RESUSCITATION MONITOR

    K Number: K973347 · Decision Jul 23, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    77
    Applicant Total
    4
    Review Days
    321

    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
    TSX PRM PULMONARY RESUSCITATION MONITOR
    K Number
    K973347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2600
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spiracle Technology
    Date Received
    September 5, 1997
    Decision Date
    July 23, 1998
    Product Code
    CAP
    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
    CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

    Similar 510(k) Clearances

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

    SINGLE USE MANOMETER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VORTRAN APM-Plus

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NS 120P-TRS Airway Pressure Gauge

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NAPA LP-15 Airway Pressure Monitor

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VORTRAN Manometer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Disposable Pressure Manometer (DPM)

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

    Other Clearances by Spiracle Technology

    K Number Device Name
    K982225 SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504
    K963755 SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR
    K953349 SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE