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510(k) Data Aggregation
K Number
K101983Device Name
CRITICAL CARE ASSESSMENT
Manufacturer
CRITICAL PATIENT CARE, INC.
Date Cleared
2010-09-21
(69 days)
Product Code
JOM
Regulation Number
870.2780Why did this record match?
Applicant Name (Manufacturer) :
CRITICAL PATIENT CARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
'Critical Care Assessment' is intended for noninvasive measurements of pulse waveforms by photoelectric plethysmography and heart rate electrocardiograph. The system is intended for use of patients in medical clinics, healthcare practices and in out-patient department of hospitals.
Device Description
Critical Care Assessment device is a microprocessor based, monitor biomedical acquisition system - it identifies, classifies, and collects ECG and Plethysmograph signals from the human body. The analog signals are converted to digital data and transferred to the personal computer via isolated USB connection. This isolation separates the human body from the main power system to ensure maximum patient safety. The patient data collected from the unit is used to perform Heart Rath Variability Analysis and obtain several detailed assessment of the Autonomic Function (Autonomic Nervous System Balance), Blood flow, Stress, Fitness and the overall health risk analysis.
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