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

    EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)

    K Number: K980725 · Decision Aug 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    102
    Applicant Total
    45
    Review Days
    181

    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
    EXHALATION VALVE (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)
    K Number
    K980725
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5870
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Instrumentation Industries, Inc.
    Date Received
    February 24, 1998
    Decision Date
    August 24, 1998
    Product Code
    CBP
    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
    CBP Valve, Non-Rebreathing

    Similar 510(k) Clearances

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

    QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    F&P Optiflow Flow Diverter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Altech® Exhalation Valve (Single Limb and Dual Limb)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CPR Face Shield

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OJR215 Pressure Relief Manifold

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)

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

    Other Clearances by Instrumentation Industries, Inc.

    K Number Device Name
    K180510 NS 120P-TRS Airway Pressure Gauge
    K162753 RTC 26-C Inline Aerosol Adapter
    K113644 PILOT TUBE REPAIR KIT
    K102127 ENDOTRACHEAL TUBE CHANGERS
    K101857 RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
    K091111 RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
    K081778 NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
    K081693 NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS
    K991355 METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
    K992670 OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067
    Search all 45 clearances from Instrumentation Industries, Inc. →