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510(k) Data Aggregation
K Number
K011597Device Name
SMARTMONITOR 2, MODEL 4000
Manufacturer
RESPIRONICS GEORGIA, INC.
Date Cleared
2002-01-11
(232 days)
Product Code
FLS
Regulation Number
868.2377Why did this record match?
Applicant Name (Manufacturer) :
RESPIRONICS GEORGIA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmartMonitor® 2 Infant Apnea Monitor is intended for use in the continuous monitoring of respiration and heart rate of infant patients in a home or hospital environment. The monitor detects and alarms for periods of central apnea and high or low heart rates.
Device Description
The SmartMonitor 2 is a monitoring device designed to monitor respiration and heart rate. Upon detection of abnormal events, SmartMonitor 2 alerts the caregiver via both visual and audible alarms and records the information for subsequent clinical review.
SmartMonitor 2 acquires the electrical activity of the heart via a two or three-lead electrode configuration. The same set of electrodes is used to measure transthoracic impedance and to subsequently develop a respiration signal. Detection of heart beats and respiration breaths is accomplished via softwarebased algorithms, which analyze the ECG and respiration signals. When beats or breaths are detected, SmartMonitor 2 provides feedback by blinking the Heart and Respiration LED's and calculates apnea intervals, average heart rates, and average breath rates for the purpose for identifying ECG and respiration rates that violate preset threshold values. In addition to the alarms, when abnormal ECG and respiration rates are detected, both tabular data and associated waveforms are logged in nonvolatile memory for subsequent review by a Health Care Professional.
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K Number
K001708Device Name
PROFOX SOFTWARE, MODEL 920M-41
Manufacturer
RESPIRONICS GEORGIA, INC.
Date Cleared
2001-03-01
(269 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
RESPIRONICS GEORGIA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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