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

    GLOBE-TROTTER GT5400

    K Number: K141565 · Decision Sep 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    48
    Review Days
    90

    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
    GLOBE-TROTTER GT5400
    K Number
    K141565
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5410
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Draeger Medical Systems, Inc.
    Date Received
    June 12, 2014
    Decision Date
    September 10, 2014
    Product Code
    FPL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FPL Incubator, Neonatal Transport

    Similar 510(k) Clearances

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

    NxtGen Infant Transport Incubator

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SREE MRI Transport Incubator

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ATOM TRANSCAPSULE V-707

    FDA 510(k)
    FDA Class 2 ·General Hospital

    A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Draeger Medical Systems, Inc.

    K Number Device Name
    K243606 Babyroo TN300
    K240312 Infinity CentralStation Wide
    K233834 Infinity Gateway Suite
    K231477 Infinity CentralStation Wide, Infinity M300, Infinity M300+
    K230278 Babyroo TN300
    K203579 Infinity Gateway Suite
    K203088 Infinity Acute Care System (IACS) Monitoring System
    K201764 Infinity Acute Care System (IACS) Monitoring Solution
    K200859 Infinity M300
    K182977 Isolette 8000 Plus
    Search all 48 clearances from Draeger Medical Systems, Inc. →