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510(k) Data Aggregation

    K Number
    K040485
    Device Name
    MAXAIR SURGICAL HELMET SYSTEM
    Manufacturer
    BIO-MEDICAL DEVICES, INC.
    Date Cleared
    2004-10-18

    (236 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MAXair® Surgical Helmet system is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The MAXair Surgical Helmet system consists of disposable surgical apparel and re-usable headgear, battery pack and accessory battery charger.
    Device Description
    The MAXair® Surgical Helmet system consists of disposable surgical apparel and re-usable headgear, battery pack and accessory battery charger. The MAXair Surgical Helmet system is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The disposable, sterile surgical apparel of the MAXair system includes an electrostatically charged meltblown fabric hood/filter and a barrier toga. The barrier material is fluid resistant to protect the wearer from fluid borne pathogens. The meltblown fabric hood/filter has passed NIOSH testing (TC-21C-0775) for PAPR's and is rated HE (High Efficiency). The non-sterile, re-usable component of the Surgical Helmet system is comprised of a self contained Helmet/blower and a battery pack. The helmet has an incorporated headgear and provides air delivery. The air delivery helmet pulls air from outside the hood/filter, through the filter media, and directs it inside to the user. The system is powered by a lithium ion battery pack. The lithium ion battery pack is recharged by an accessory battery charger.
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    K Number
    K981888
    Device Name
    SMOKE-EVAC
    Manufacturer
    BIO-MEDICAL DEVICES, INC.
    Date Cleared
    1998-10-15

    (139 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A vacuum powered body fluid (smoke) suction apparatus that is used to remove body fluids. In this particular case the fluid is the smoke that is generated during electrosurgical procedures. The device is powered by an external source of vacuum. This device includes rigid suction tubes, tips, and connecting tubes.
    Device Description
    A vacuum powered body fluid (smoke) suction apparatus that is used to remove body fluids. In this particular case the fluid is the smoke that is generated during electrosurgical procedures. The device is powered by an external source of vacuum. This device includes rigid suction tubes, tips, and connecting tubes.
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    K Number
    K955149
    Device Name
    MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL
    Manufacturer
    BIO-MEDICAL DEVICES, INC.
    Date Cleared
    1996-01-24

    (72 days)

    Product Code
    BYY
    Regulation Number
    880.6740
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K955151
    Device Name
    MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR
    Manufacturer
    BIO-MEDICAL DEVICES, INC.
    Date Cleared
    1996-01-24

    (72 days)

    Product Code
    BYY
    Regulation Number
    880.6740
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K955150
    Device Name
    MAXI-FLOW
    Manufacturer
    BIO-MEDICAL DEVICES, INC.
    Date Cleared
    1996-01-23

    (71 days)

    Product Code
    BYY
    Regulation Number
    880.6740
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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