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

    RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE

    K Number: K780385 · Decision May 16, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    108
    Registration Numbers
    108
    Same Product Code
    220
    Applicant Total
    206
    Review Days
    67

    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
    RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE
    K Number
    K780385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5450
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Travenol Laboratories, S.A.
    Date Received
    March 10, 1978
    Decision Date
    May 16, 1978
    Product Code
    BTT
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

    Similar 510(k) Clearances

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

    HVT 2.0

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FL-10000U Respiratory Humidifier

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Laboratorios Biogalenic Sterile Water for Inhalation, USP

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)

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

    Other Clearances by Travenol Laboratories, S.A.

    K Number Device Name
    K874181 BAXTER BEDSIDE SYSTEM
    K873894 CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE
    K873873 RESUBMITTED MICRON TRANSFUSION FILTER
    K873984 AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)
    K872364 HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
    K872652 UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM
    K870801 FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD
    K871908 IV ADMINISTRATION SET
    K871471 CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15
    K865029 CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
    Search all 206 clearances from Travenol Laboratories, S.A. →