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

    PREEMICARE MODEL 2500 TRANSPORT WARMER

    K Number: K893624 · Decision Sep 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    9
    Review Days
    139

    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
    PREEMICARE MODEL 2500 TRANSPORT WARMER
    K Number
    K893624
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5410
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Preemicare Corp.
    Date Received
    May 11, 1989
    Decision Date
    September 27, 1989
    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

    GLOBE-TROTTER GT5400

    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
    View all

    Other Clearances by Preemicare Corp.

    K Number Device Name
    K911450 INFANT VENTILATOR
    K896375 PREEMICARE NEBUTECH NEBULIZER SYSTEM
    K900735 MODEL 130 AUTOMATIC HEIGHT ADJUST (AHA) INCUBATOR
    K893622 PREEMICARE MODEL 200-II INFANT TRANSPORT VENTIL.
    K891674 NEONATAL ENVIRONMENTAL MONITOR, MODEL 275
    K885350 PREEMICARE SERIES 2000 INFANT WARMER
    K884133 PREEMICARE SERIES 4000 PHOTOTHERAPY LAMP
    K881476 PREEMICARE MODEL D1-X1, SERIES 3000