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

    HRV ACQUIRE

    K Number: K092809 · Decision Oct 19, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    338
    Applicant Total
    6
    Review Days
    403

    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
    HRV ACQUIRE
    K Number
    K092809
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wr Medical Electronics Co.
    Date Received
    September 11, 2009
    Decision Date
    October 19, 2010
    Product Code
    DRT
    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
    DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

    Similar 510(k) Clearances

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

    The Circadia C300 System (C300)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    The Circadia C300 System (C300)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sleepiz One+ (Model 2.5)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sleepiz One+ (2.5)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    The Circadia C200 System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software

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

    Other Clearances by Wr Medical Electronics Co.

    K Number Device Name
    K063560 HILGER DUAL-STIM NERVE STIMULATOR
    K000574 IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)
    K992874 Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM
    K910624 CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4
    K895838 BRACKMANN EMG MONITORING SYSTEM