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

    ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON

    K Number: K802282 · Decision Oct 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    23
    Applicant Total
    15
    Review Days
    21

    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
    ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON
    K Number
    K802282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2050
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Consolidated Medical Equipment, Inc.
    Date Received
    September 19, 1980
    Decision Date
    October 10, 1980
    Product Code
    DRR
    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
    DRR Amplifier And Signal Conditioner, Biopotential

    Similar 510(k) Clearances

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

    BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EP AMP, MODEL #901

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HORIZON 9000/HIS OPTION AMPLIFIER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARDIOLAB AMPLIFIER MODULE (CAM)

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

    Other Clearances by Consolidated Medical Equipment, Inc.

    K Number Device Name
    K854040 I.V. DRESSING
    K850132 DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC
    K850130 PRN ECG ELECTRODE
    K850037 CLOSED WOUND DRAIN
    K844942 PLURA-GARD CHEST DRAINAGE SYSTEM
    K850311 DISPOS. CONDUCTIVE ADHESIVE TENS PAD
    K850131 CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS
    K850129 MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN
    K850133 VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.
    K844372 HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE
    Search all 15 clearances from Consolidated Medical Equipment, Inc. →