BEUDAMED
    Product Code: MNT FDA class 2 21 CFR 868.5895

    Sv70 Ventilator

    Anesthesiology

    The Continuous Ventilator for Minimal Ventilatory Support (Facility Use) is a respiratory device intended for use in clinical facilities to provide minimal, continuous ventilatory support to patients. Classified as FDA Class 2 under 21 CFR 868.5895 in the Anesthesiology specialty, it requires 510(k) premarket notification. The product code is MNT, and it carries a life-sustaining support flag, indicating it is used to sustain patient life.

    View on FDA
    510(k)s
    25
    FEI Numbers
    27
    Registration Numbers
    27
    Unique Applicants
    14
    Years Active
    30

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    Basic Information

    Product Code
    MNT
    Device Class
    FDA class 2
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✓
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 25 510(k) clearances via K numbers.

    K Number Device Name
    K252182 SV70 Ventilator (SV70)
    K242931 HFT750U
    K240779 Vivo 3
    K233643 F&P Airvo 3 NIV (PT311US)
    K230173 Servo-air Lite Ventilator System
    K213521 Nihon Kohden NKV-330 Ventilator System
    K191624 F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
    K170367 Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small
    K122715 STELLAR 150
    K121623 BIPAP A 40 VENTILATORY SUPPORT SYSTEM
    K113640 STELLAR 150
    K102985 V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
    K103167 STELLAR 150
    K090113 BREAS VIVO 40 SYSTEM
    K082660 V60 VENTILATOR, MODEL V8000
    K071702 BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40
    K060044 ACUTE CARE FACE MASK, MODEL RT040
    K053607 BREAS VIVO 40 SYSTEM
    K003075 KNIGHTSTAR 330 VENTILATOR
    K990574 STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
    K982454 BIPAP VISION VENTILATORY SUPPORT
    K974539 SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM
    K973004 KNIGHTSTAR 335
    K955324 BIPAP S/T-D 30 SYSTEM
    K951264 BIPAP MODEL S/T-D

    FEI Numbers

    This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.