BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DALE COMBO TRACHEOSTOMY TUBE HOLDER

    K Number: K812429 · Decision Sep 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    48
    Applicant Total
    13
    Review Days
    29

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    Basic Information

    Device Name
    DALE COMBO TRACHEOSTOMY TUBE HOLDER
    K Number
    K812429
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4350
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Dale Medical Products, Inc.
    Date Received
    August 25, 1981
    Decision Date
    September 23, 1981
    Product Code
    EQH
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EQH Source, Carrier, Fiberoptic Light

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    Other Clearances by Dale Medical Products, Inc.

    K Number Device Name
    K082241 THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751
    K994300 NASOGASTRIC TUBE HOLDER, MODEL 160
    K964399 DALE ENDOTRACHEAL TUBE HOLDER 270/280
    K961693 DALE GASTROSTOMY TUBE HOLDER
    K951491 DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS
    K914245 DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)
    K905231 DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT.
    K894586 DALE I.V. IDENTIFIER; PRODUCT #1125
    K873311 DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220
    K864897 DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
    Search all 13 clearances from Dale Medical Products, Inc. →