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

    HFD100 ROCKER ARM ACCESSORY

    K Number: K141950 · Decision Sep 4, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    49
    Applicant Total
    14
    Review Days
    48

    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
    HFD100 ROCKER ARM ACCESSORY
    K Number
    K141950
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imris, Inc.
    Date Received
    July 18, 2014
    Decision Date
    September 4, 2014
    Product Code
    HBL
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBL Holder, Head, Neurosurgical (Skull Clamp)

    Similar 510(k) Clearances

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

    mb-FIX Cranial Stabilization Systems

    FDA 510(k)
    FDA Class 2 ·Neurology

    DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DORO QR3 Headrest System (Aluminum)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)

    FDA 510(k)
    FDA Class 2 ·Neurology

    DORO LUCENT® iXI and iMRI Headrest System

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

    Other Clearances by Imris, Inc.

    K Number Device Name
    K143420 SYMBIS Surgical System
    K133692 IMRI 1.5T AND IMRI 3T S
    K130224 ICT
    K123091 VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
    K121997 IMRIS ONCOLOGY PACKAGE
    K113748 IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)
    K103493 HEAD FIATION DEVICE (HFD 100)
    K103506 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
    K101813 IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
    K091166 IMRX
    Search all 14 clearances from Imris, Inc. →