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

    FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT

    K Number: K932417 · Decision Sep 9, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    24
    Applicant Total
    5
    Review Days
    114

    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
    FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT
    K Number
    K932417
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5410
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ferno-Washington, Inc.
    Date Received
    May 18, 1993
    Decision Date
    September 9, 1993
    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 Ferno-Washington, Inc.

    K Number Device Name
    K980033 FERNO HEALTHCARE RECLINE-A-BATH 2
    K864765 MODEL 668, TRACTION SPLINT, ADULT
    K864269 MODEL 35-B ALL LEVEL COT
    K862441 EZ LOAD MODEL 30, ALL LEVEL COT