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

    ISOLATION MASK I.C.S.

    K Number: K831062 · Decision Apr 13, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    11
    Applicant Total
    20
    Review Days
    5

    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
    ISOLATION MASK I.C.S.
    K Number
    K831062
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5450
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    American Threshold Industries, Inc.
    Date Received
    April 8, 1983
    Decision Date
    April 13, 1983
    Product Code
    LGM
    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
    LGM Chamber, Patient Isolation

    Similar 510(k) Clearances

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

    Carecube Negative Pressure Isolation Chamber

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ORCA (tm) - Operational Rescue Containment Apparatus

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PATIENT ISOLATION UNIT, MODEL G019-1000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MTB 1043 TREATMENT BOOTH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM

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

    Other Clearances by American Threshold Industries, Inc.

    K Number Device Name
    K971483 SECURE-WRAP (TM) STERILIZATION WRAP
    K953879 SURGEON'S CAP
    K953878 BOUFFANT CAP
    K952114 KOOL GARD SINGLES GOWN
    K952115 BARRIER GOWN, KOOL-GARD BACKLESS GOWN
    K952116 COVER GOWN
    K934085 MODIFICATION OF SURGICAL EYESHIELD MASK
    K915530 NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE
    K915740 DISPOSABLE O.R. TOWEL, STERILE
    K912110 DISPOSABLE O.R. TOWEL
    Search all 20 clearances from American Threshold Industries, Inc. →