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

    THERMO-K

    K Number: K820814 · Decision Apr 29, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    157
    Applicant Total
    72
    Review Days
    36

    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
    THERMO-K
    K Number
    K820814
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    American Medical Systems, Inc.
    Date Received
    March 24, 1982
    Decision Date
    April 29, 1982
    Product Code
    DWJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DWJ System, Thermal Regulating

    Similar 510(k) Clearances

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

    Hot Pink Pad Warming System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Warming System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arctic Sun Temperature Management System (Model 5000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Celsi Warmer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arctic Sun Stat Temperature Management System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HotDog Warming Mattress + Return Electrode

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by American Medical Systems, Inc.

    K Number Device Name
    K132655 RETROARC RETROPUBIC SLING SYSTEM
    K112842 AMS ELEVATE PC
    K100807 MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
    K092735 GREENLIGHT XPS LASER SYSTEM
    K090934 PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
    K090663 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
    K090713 ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
    K082677 AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
    K082730 AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
    K082006 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
    Search all 72 clearances from American Medical Systems, Inc. →