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

    SURETEMP PLUS

    K Number: K030580 · Decision May 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    111
    Review Days
    71

    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
    SURETEMP PLUS
    K Number
    K030580
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Welch Allyn, Inc.
    Date Received
    February 24, 2003
    Decision Date
    May 6, 2003
    Product Code
    FLL
    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
    FLL Continuous Measurement Thermometer

    Similar 510(k) Clearances

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

    Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Infrared Thermometer

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

    Other Clearances by Welch Allyn, Inc.

    K Number Device Name
    K243598 Welch Allyn Connex® 360 (Multiple)
    K241411 Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)
    K223381 iExaminer System with Panoptic Plus
    K212473 Welch Allyn Connex Central Station
    K191013 Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
    K181016 Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
    K171621 Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
    K142356 Connex Spot Monitor,901058 Vital Signs Monitor Core
    K132807 MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
    K132808 VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
    Search all 111 clearances from Welch Allyn, Inc. →