BEUDAMED
    Product Code: MNS FDA class 2 21 CFR 868.5895

    Ventilator, Continuous, Non-Life-Supporting

    Anesthesiology

    The Continuous Non-Life-Supporting Ventilator is a respiratory device designed to provide continuous ventilatory support to patients who do not rely on the device for survival, typically used for comfort or mild respiratory support. Classified as FDA Class 2 under 21 CFR 868.5895 in the Anesthesiology specialty, it requires 510(k) premarket notification. The product code is MNS.

    View on FDA
    510(k)s
    47
    FEI Numbers
    33
    Registration Numbers
    33
    Unique Applicants
    15
    Years Active
    30

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    Basic Information

    Product Code
    MNS
    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 47 510(k) clearances via K numbers.

    K Number Device Name
    K251889 myAir
    K252078 BreathePal Bilevel (GFM50-MD2201)
    K251661 Mariana Minerva; Mariana Nimbus
    K240778 Vivo 1, Vivo 2
    K231064 ReddyPort Elbow
    K213169 BPAP System
    K171827 ReddyPort NIV Access Elbow
    K161492 Juno VPAP ST-A
    K161487 VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
    K153061 Juno VPAP ST-A
    K132371 EASYCARE ONLINE
    K123511 S9 VPAP TX
    K123557 EASYCARE ONLINE
    K122324 VPAP S-A
    K113714 VPAP TX
    K113288 VPAP ST-A
    K113815 RESSCAN
    K113053 BIPAP A 30 VENTILATORY SUPPORT SYSTEM
    K112914 VPAP TX
    K111378 OXIMETRY INTERFACE KIT
    K102465 BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
    K101130 BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
    K093731 VPAP III ST-A
    K093070 DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES
    K092818 BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
    K092186 VPAP TX
    K090539 BIPAP AUTOSV ADVANCED
    K092043 BIPAP SYNCHRONY 2
    K090248 BIPAP AUTOSV
    K071509 BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM
    K070328 BIPAP SYNCHRONY WITH AVAPS
    K063540 BIPAP AUTOSV
    K063533 BIPAP SYNCHRONY
    K060546 BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30
    K060105 VPAP III ST-A/KIDSTA MASK SYSTEM
    K053168 BIPAP FOCUS
    K051364 VPAP ADAPT
    K033276 VPAP III ST-A
    K031896 NASAL-AIR CRITICAL CARE
    K031656 BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
    K020777 BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
    K012323 BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
    K992530 BIPAP SYNCHRONY HC
    K984407 BIPAP HARMONY S/T, MODEL 1001445
    K974417 SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM
    K962517 MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV
    K942210 PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.