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

    DEFIBRILLATOR ANALYZER, DELTA 1000

    K Number: K961595 · Decision Oct 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    18
    Applicant Total
    1
    Review Days
    188

    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
    DEFIBRILLATOR ANALYZER, DELTA 1000
    K Number
    K961595
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5325
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Netech Corp.
    Date Received
    April 24, 1996
    Decision Date
    October 29, 1996
    Product Code
    DRL
    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
    DRL Tester, Defibrillator

    Similar 510(k) Clearances

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

    Delta 3300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UniPulse

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Defibrillator Analyzer Variable Load

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEFIBRILLATOR ANALYZER - DA-2006P

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    IMPULSE 6000D/7000DP

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