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

    FILAC FAS TEMP ELECTRONIC THERMOMETER

    K Number: K003313 · Decision Jan 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    8
    Review Days
    80

    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
    FILAC FAS TEMP ELECTRONIC THERMOMETER
    K Number
    K003313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    The Kendall Company
    Date Received
    October 23, 2000
    Decision Date
    January 11, 2001
    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 The Kendall Company

    K Number Device Name
    K061936 KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311
    K030209 MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
    K020089 MAHURKAR TRIPLE LUMEN CATHETER, 12 FR
    K011283 MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE
    K011941 EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
    K002902 TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERS
    K002901 KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER