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

    ADVANCED NIBP MODULE

    K Number: K982641 · Decision Mar 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    53
    Review Days
    243

    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
    ADVANCED NIBP MODULE
    K Number
    K982641
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Medical, Inc.
    Date Received
    July 29, 1998
    Decision Date
    March 29, 1999
    Product Code
    DXN
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    Similar 510(k) Clearances

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

    Wrist Blood Pressure Monitor (XW-05)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VicorderCS (VCS-SYS-1100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Upper arm electronic blood pressure monitor (XB-01)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Blood Pressure Monitor (W06LT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)

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

    Other Clearances by Johnson & Johnson Medical, Inc.

    K Number Device Name
    K001690 PROTECTIV SAFETY BLOOD COLLECTION NEEDLE
    K983362 NU-GEL * WOUND DRESSING
    K982597 FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
    K974080 CRITIKON SOFT BLOOD PRESSURE CUFF
    K980493 I.V. CATHETER SYSTEM
    K972498 OBSERVER * CENTRAL STATION
    K973699 ULTRALON POWDER FREE LATEX SURGICAL GLOVE
    K971569 DINAMAP MPS PORTABLE MONITOR
    K970182 DINAMAP COMPACT MONITOR
    K964556 HR POLYURETHANE PICC AND MIDLINE CATHETERS
    Search all 53 clearances from Johnson & Johnson Medical, Inc. →