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

    AMBI-24 PH/PRESSURE MONITOR

    K Number: K854514 · Decision Feb 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    48
    Applicant Total
    70
    Review Days
    104

    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
    AMBI-24 PH/PRESSURE MONITOR
    K Number
    K854514
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Biosearch Medical Products, Inc.
    Date Received
    November 12, 1985
    Decision Date
    February 24, 1986
    Product Code
    FFT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FFT Electrode, Ph, Stomach

    Similar 510(k) Clearances

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

    BRAVO PH MONITORING SYSTEM AND ACCESSORIES

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    SANDHILL SCIENTIFIC PEDIATEC PH PROBE

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    BRAVO PH MONITORING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    PH ANALYSIS MODULE

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    LOT 440

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology
    View all

    Other Clearances by Biosearch Medical Products, Inc.

    K Number Device Name
    K051480 ENTERAL FEEDING TUBE
    K970145 PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
    K964871 BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
    K951260 URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
    K944614 MEGA-BRUSH, ENDOSCOPIC MASS CYTOLOGY - CELLUAR RETRIEVAL SYSTEM
    K932295 NON-BALLOON REPLACEMENT GASTROSTOMY KIT
    K935045 BIOSEARCH LAPROSCOPIC GASTRONOMY CATHETER
    K923002 ENTEROCLYSIS TUBE
    K934193 CELL-MATE(TM) MASS CYTOLOGY-CELLULAR RETRIEVAL SYST
    K922987 LAPSTICK LAPAROSCOPIC SPONGE STICK/ BLUNT DISSEC.
    Search all 70 clearances from Biosearch Medical Products, Inc. →