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

    CARDIO ANALYZER MODEL 380

    K Number: K844104 · Decision Mar 6, 1985
    View on FDA
    Classifications
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    82
    Applicant Total
    27
    Review Days
    134

    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
    CARDIO ANALYZER MODEL 380
    K Number
    K844104
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Applicant
    Birtcher Corp.
    Date Received
    October 23, 1984
    Decision Date
    March 6, 1985
    Product Code
    LOS
    Advisory Committee
    Unknown
    Review Advisory Committee
    CV
    Third Party
    N

    Similar 510(k) Clearances

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

    EKG-PLUS II SOFTWARE

    FDA 510(k)

    CARDIOVIEW32 REVIEW MODULE

    FDA 510(k)

    PHILIPS ECG ALGORITHM

    FDA 510(k)

    CARDIOTOUCH-3000

    FDA 510(k)

    CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH

    FDA 510(k)

    CARDIO-CARD INTERPRETATION SYSTEM I

    FDA 510(k)

    Other Clearances by Birtcher Corp.

    K Number Device Name
    K881328 MODEL 375 ECG
    K860718 ELECTROSURGERY PENCIL, MODEL 767
    K860687 BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768
    K854814 SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33
    K854864 BI-POLAR FORCEPS
    K850668 ELECTROSURGICAL UNIT 774
    K850943 MODEL 775 BIPOLAR COAGULATOR
    K844101 CARDIO-NEC MODEL 365
    K850297 ELECTROSURGICAL PENCIL HOLDER 720
    K844103 CARDIOPAC DEFIBRILLATOR 444
    Search all 27 clearances from Birtcher Corp. →