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

    PENTAX BRONCHOFIBERSCOPE #FB-19E

    K Number: K822844 · Decision Oct 26, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    67
    Review Days
    33

    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
    PENTAX BRONCHOFIBERSCOPE #FB-19E
    K Number
    K822844
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Pentax Precision Instrument Corp.
    Date Received
    September 23, 1982
    Decision Date
    October 26, 1982
    Product Code
    EOQ
    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
    EOQ Bronchoscope (Flexible Or Rigid)

    Similar 510(k) Clearances

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

    FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SmartClip Delivery Catheter (ADR-1715)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    FUJIFILM Ultrasonic Endoscope EB-710US

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat
    View all

    Other Clearances by Pentax Precision Instrument Corp.

    K Number Device Name
    K041396 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K041395 EG-3630UR
    K041397 EG-3830UT
    K031789 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K023401 EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
    K023376 EB-1830T3, VIDEO BRONCHOSCOPE
    K021276 FG-36UX FIBER ULTRASOUND GASTROSCOPE
    K021278 EG-3630UR, ULTRASOUND VIDEO GASTROSCOPE
    K013640 EG-3630UR, ULTRASUND VIDEO GASTROSCOPE
    K010740 FG-36UX, FIBER ULTRASOUND GASTROSCOPE
    Search all 67 clearances from Pentax Precision Instrument Corp. →