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

    VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)

    K Number: K964978 · Decision May 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    164
    Review Days
    160

    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
    VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
    K Number
    K964978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quinton, Inc.
    Date Received
    December 12, 1996
    Decision Date
    May 21, 1997
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    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
    DQA Oximeter

    Similar 510(k) Clearances

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

    Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AViTA Pulse Oximeter (SP61)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)

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

    Other Clearances by Quinton, Inc.

    K Number Device Name
    K032038 PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601
    K021906 QUINTON Q-CATH, MODEL 000460
    K003576 Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
    K001492 QUINTON Q-STRESS, MODEL 000483
    K992908 Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
    K990866 QUINTON MEDTRACK CR PLUS TREADMILL
    K971397 VIEWCATH 3-D CATHETER PULLBACK
    K964784 SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431)
    K955002 MAHURKAR 8 FR DUAL LEMEN CATHETER
    K961014 QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH
    Search all 164 clearances from Quinton, Inc. →