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

    VASO PRESS SYSTEM

    K Number: K974393 · Decision Mar 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    17
    Review Days
    483

    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
    VASO PRESS SYSTEM
    K Number
    K974393
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Britt Corp., Inc.
    Date Received
    November 21, 1997
    Decision Date
    March 19, 1999
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

    Similar 510(k) Clearances

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

    Compression Therapy Device (LGT-2202DVT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NanoPress 760A-BT (760A-BT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bio Arterial Deluxe (IC-BAP-DX)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sequential Compression System (SCD600)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PlasmaFlow X Compression Sleeve Device (XPF0001)

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

    Other Clearances by Britt Corp., Inc.

    K Number Device Name
    K003828 VASO PRESS DVT FOOT GARMENT #VP 520
    K991038 VASO PRESS DVT SYSTEM, MODELS VP500, VP501
    K860977 MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION
    K860975 MODEL 545-45 LASER FOR EAR, NOSE & THROAT
    K860974 MODEL 545-45 LASER FOR DERMA., POD., SURGICAL
    K860277 MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT
    K860273 MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY
    K860278 MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC
    K851425 MODEL J25-25 WATT CO2 LASER
    K840020 FITNESS LOGGER
    Search all 17 clearances from Britt Corp., Inc. →