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510(k) Data Aggregation
K Number
K132026Device Name
V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21
Manufacturer
MINDRAY DS USA, INC.
Date Cleared
2013-12-20
(172 days)
Product Code
MHX, CBQ, CBR, CBS, CCK, CCL, DQA, DQK, DRT, DSI, DSK, DXG, DXN, FLL, GWM, MLD, MUD, NHO, NHP, NHQ
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
MINDRAY DS USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The V Series Monitoring System is intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters:
- . ECG waveform derived from 3, 5, 6 and 12 Lead measurements
- . Heart Rate
- . Pulse Oximetry (SpO2)
- ST Segment Analysis ●
- . Arrhythmia Detection
- . Non Invasive Blood Pressure (NIBP)
- Invasive Blood Pressure (IBP) .
- Cardiac Output (CO) .
- . Respiratory Gasses
- . Respiration Rate
- . Temperature
The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
Device Description
The V Series Monitoring System is a multi physiological parameter patient monitor. It is a modular system that allows the user to customize monitored parameters based on a patient's need or acuity level.
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K Number
K102471Device Name
AS3700 ANESTHSIA DELIVERY SYSTEM
Manufacturer
MINDRAY DS USA, INC.
Date Cleared
2011-02-11
(165 days)
Product Code
BSZ
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
MINDRAY DS USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AS3700 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
The AS3700 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations.
Device Description
The AS3700 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
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K Number
K102004Device Name
ENDEAVOUR MONITORING SYSTEM
Manufacturer
MINDRAY DS USA, INC.
Date Cleared
2010-09-10
(57 days)
Product Code
MHX
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
MINDRAY DS USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endeavour Monitoring System is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters:
- ECG waveform derived from 3, 5, 6 and 12 lead measurements
- Heart Rate
- Pulse Oximetry (SpO2)
- ST Segment Analysis
- Arrhythmia Detection
- Non Invasive Blood Pressure (NIBP)
- Invasive Blood Pressure (IBP)
- Cardiac Output (CO)
- Respiratory Gasses
- Respiration Rate
- Temperature
The Endeavour Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
The target populations are adult, pediatric and neonate with the exception of:
- Arrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only,
- IV Drug Calculations for which the target population is adult only, and
- Cardiac Output for which the target population is adult and pediatric only.
Device Description
The Endeavour Monitoring System is a multi physiological parameter patient monitor. It is a modular system that allows users to customize monitored parameters based on a patients monitoring need or acuity level.
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