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510(k) Data Aggregation
K Number
K112877Device Name
COMEN MULTI-PARAMETER PATIENT MONITOR
Manufacturer
GOLDWAY (US), INC.
Date Cleared
2012-11-07
(404 days)
Product Code
MWI, DPS, DQA, DXN, FLL
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
GOLDWAY (US), INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Comen Multi-Parameter Patient Monitor models C50, C60, C80 are intended to monitor basic physiological parameters of patients within any professional medical environment. The user, responsible for interpreting the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data will be made available to the user from the monitor.
The monitor models monitor parameters such as ECG (3-lead, 5-lead), Respiration (RESP), pulse oximetry (SpO2), noninvasive blood pressure (NIBP) and surface body and rectal temperature (TEMP) only. The models are equipped with alarms that indicate system faults, physiological parameters that have exceeded the limits set by the operator, or both.
The monitor models do not measure, display or trend changes in the ST segment, do not detect arrhythmia or provide arrhythmia alarm, and is not intended for use as an apnea monitor. The models are not intended for use during MRI or CT scans.
The monitor models are not designed for home use, and are restricted to be used on one patient at a time.
Device Description
COMEN Multi-Parameter Patient Monitor Models C50, C60 and C80 obtain and display physiological data of the patient including waveforms and numerical data in real time. COMEN C series can be custom confiqured to monitor electrocardiograph (ECG), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), respiration (RESP) or temperature (TEMP). These physiological signals are converted into digital data and displayed.
For each parameter, COMEN C series examine the data for alarm conditions and present them on the display. COMEN C series have audio alarming function that may raise the user's attention of system error or as dictated by the physiological parameter settings.
COMEN C series are capable of storing data trends for retrospective review and sending serial port signal to printer for report printing.
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K Number
K033988Device Name
GOLDWAY UT4000A VITAL SIGNS MONITOR
Manufacturer
GOLDWAY (US), INC.
Date Cleared
2004-02-25
(64 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
GOLDWAY (US), INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Goldway UT4000A Vital Signs Monitor is intended to monitor basic physiological parameters of patients from adults to neonates within any professional medical environment. The user, responsible to interpret the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data analysis will be made available to the user from the monitor.
Physiological data includes: electrocardiograph, non-invasive blood pressure, and pulse oximetry.
Goldway UT4000A is not intended for use as an apnea monitor. Goldway UT4000A is not intended for use during MRI or CT scans.
The UT4000A is not designed for home use. The device is restricted to be used on one patient at a time.
Device Description
The Goldway UT4000A monitor interprets and displays physiological data of the patient including waveforms and numerical data in real time. Goldway UT4000A can be custom configured to monitor electrocardiograph (ECG), non-invasive blood pressure (NIBP), or pulse oximetry (SpO2). For each patient vital parameter, Goldway UT4000A will be capable of providing limit alarms and alerts, storing data trends for retrospective review and sending serial port signal to printer for report printing.
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