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510(k) Data Aggregation
K Number
K132662Device Name
PASSPORT SERIES PATIENT MONITORS
Manufacturer
SHENZHEN MINDRAY BIOMEDICAL ELECTRONICS CO. LTD
Date Cleared
2014-08-01
(340 days)
Product Code
MHX, CBQ, CBR, CBS, CCK, CCL, DPZ, DQA, DRT, DSI, DSK, DXG, DXN, FLL, MLD
Regulation Number
870.1025Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN MINDRAY BIOMEDICAL ELECTRONICS CO. LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Passport Series Patient Monitors, including Passport 8 and Passport 12, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration (Resp), temperature (Temp), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), and anesthetic gas (AG).
All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following:
- · C.O. monitoring is restricted to adult patients only;
- · PAWP monitoring is not intended for neonatal patients;
- · The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients. The Mindray ECG Algorithm arrhythmia detection is intended for adult and pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only.
- · 12-lead monitoring and AG monitoring are available for Passport 12 Patient Monitors only.
The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.
Device Description
The Passport Series Patient Monitors (including Passport 12) are the developed new series based on the technical platform of the iPM Series patient monitors.
Comparing with the cleared iPM Series Patient Monitors, the WiFi function is added on the subject patient monitors.
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