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

    Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M

    K Number: K152363 · Decision Oct 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    107
    Review Days
    68

    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
    Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
    K Number
    K152363
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Philips Medical Systems
    Date Received
    August 20, 2015
    Decision Date
    October 27, 2015
    Product Code
    DXQ
    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
    DXQ Blood Pressure Cuff

    Similar 510(k) Clearances

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

    YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Disposable Neonatal NIBP Cuff (U1681S-C51N)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AViTA Arm Type Blood Pressure Monitor Cuff

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)

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

    Other Clearances by Philips Medical Systems

    K Number Device Name
    K212704 Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
    K211597 EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
    K210560 Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
    K191738 PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph
    K192875 Philips Biosensor BX100
    K183387 M3290B Patient Information Center iX
    K180017 MX40 Release C.01
    K172226 MX40 Release B.07
    K163584 M3290B Philips IntelliVue Information Center iX
    K163649 SureSigns VS3; SureSigns VS4
    Search all 107 clearances from Philips Medical Systems →