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510(k) Data Aggregation

    K Number
    K120234
    Device Name
    EZONO 3000
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2012-04-19

    (85 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE-TECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the eZono 3000, as defined by FDA guidance documents, are: Ophthalmic, Musculo-skeletal (Conventional), Fetal (as enumerated in the IFU Tables), Musculo-skeletal (Superficial), Abdominal, Retroperitoneum, Pediatric, Female reproductive system and foetus, Small Organ (breast, thyroid, testicle), Cardiac (Adult), Invasive diagnostic or therapeutic procedures, Cardiac (Pediatric), Peripheral vessel. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify), Intra-operative (Neuro), Laparoscopic, Pediatric, Small Organ (e.g. testicles, lymph nodes, thyroid), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans-esoph. (non-Card.), Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Intravascular, Invasive diagnostic or therapeutic procedures (e.g. biopsies, punctures, free fluid detection, regional anesthesia, vascular access), Superficial structures & pathologies (incl. Lungs), Cardiac Adult, Cardiac Pediatric, Intravascular (Cardiac), Trans-esoph. (Cardiac), Intra-cardiac, Other (Specify), Peripheral vessel.
    Device Description
    eZono 3000
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    K Number
    K111355
    Device Name
    ECHOBRIGHT
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2011-09-16

    (123 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE-TECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K102813
    Device Name
    EZONO 3000
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2011-06-30

    (275 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE-TECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K102007
    Device Name
    PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2010-12-22

    (159 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE-TECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The interestly and analogs'is vila lions For Ose. The 1977 her in and analgesia vila blockade of peripheral nerves.
    Device Description
    Not Found
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    K Number
    K093662
    Device Name
    ECHOBRIGHT
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2010-06-24

    (211 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE-TECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Echobright Kit is for regional anestheria and analgesia via blockade of peripheral nerves.
    Device Description
    Not Found
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    K Number
    K093485
    Device Name
    VESISCAN
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2010-03-16

    (127 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE-TECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vesiscan is used to measure bladder volume.
    Device Description
    Not Found
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    K Number
    K082772
    Device Name
    STIMPRO, MODELS SP22050, SP20100, SPP19050, SPP19100, SPP19150, SPC19050, SPC19100, SPC19150, SPC18050,SPC18100,SPC18150
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2009-02-09

    (140 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE-TECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shinfra is weed to administer peripheral nerve blocks,
    Device Description
    Not Found
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    K Number
    K082056
    Device Name
    ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2008-11-07

    (109 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE-TECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARM-1 is interdad to enable the Urolab equipment to measure and record the functioning of a patient's anorectal. function.
    Device Description
    Ano-Rectal Manometry Option (ARM-1)
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    K Number
    K082923
    Device Name
    PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2008-10-24

    (23 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE-TECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Prolong is for local anesthesia and analgesia via blockade of peripheral nerves.
    Device Description
    Not Found
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    K Number
    K081864
    Device Name
    PROLONG
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2008-09-25

    (86 days)

    Product Code
    BSP
    Regulation Number
    868.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFE-TECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the ProLong Centinuous Nerve Block set is for prolonged regional anesthesia and analgesia via blockade of peripheral nerves.
    Device Description
    Not Found
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