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

    DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING

    K Number: K924277 · Decision Dec 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    21
    Review Days
    834

    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
    DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING
    K Number
    K924277
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1640
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chalgren Enterprises, Inc.
    Date Received
    August 25, 1992
    Decision Date
    December 7, 1994
    Product Code
    HLT
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HLT Preamplifier, Ac-Powered, Ophthalmic

    Similar 510(k) Clearances

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

    TOMEY PE-300 PORTABLE ERG

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PANORAMIC LOUPES - VARIOUS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ORBIOGRAPH

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

    Other Clearances by Chalgren Enterprises, Inc.

    K Number Device Name
    K982950 FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550
    K960591 RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STP
    K955335 DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE
    K953356 EMG RECORDING RING ELECTRODE
    K953354 EMG DISC RECORDING ELECTRODE
    K953361 EMG DISC RECORDING ELECTRODE
    K952690 EMG DISC RECORDING ELECTRODE WITH PIN
    K952908 EMG DISC RECORDING ELECTRODE WITH PIN
    K953886 RE-USABLE MONOPOLAR NEEDLE
    K953887 RE-USABLE CONCENTRIC NEEDLE
    Search all 21 clearances from Chalgren Enterprises, Inc. →