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510(k) Data Aggregation
K Number
K954163Device Name
RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER
Manufacturer
Date Cleared
1996-07-11
(310 days)
Product Code
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
CARDIAC EVALUATION CENTER, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The sole intended use for the device or its predicate is for the long term monitoring of ECG in occasionally symptomatic patients. The purpose of both devices is to record occasional short-lived arrhythmia. Their usage is usually confined to otherwise healthy individuals on an out-patient basis. These recorders are not meant for use in life support or ICU situations. Their normal function is to record all ECG data and save a particular episode only when activated by the patient. The stored episode contains data before and after the activation so that the actual arrhythmia will be captured. The data is then saved for transmission to a qualified technician for interpretation. The recorders take no action and advises none to the patient other than to call the receiving station. They are totally passive devices and offers no diagnosis or perform any signal analysis.
Device Description
The Retrospective II is a portable ECG memory loop recorder. It is a non-critical Type II device. The device, as well as its predicate, continuously record ECG and store several minutes of the most recent data. When the patient experiences a symptom he/she presses a button which saves this stored data. The patient then calls a receiving service and transmits the data over the telephone. The service is then able to interpret or forward the data to the patient's physician. Both the Retrospective and the Retrospective II-Elite have this same operational sequence. Both devices obtained ECG data via 3 or 5 disposable surface electrodes. The ECG signals are amplified and then digitized. A microprocessor controls the sampling of the data and then stores the data in RAM. When the symptom button is pressed the most recent stored data is then saved. When the send button is presses the saved data is recalled by the microprocessor The data is then frequency modulated and used to drive a speaker. This audio data is transmitted over a voice grade telephone line to the receiving hardware. Both devices accomplish this entire process using solid-state techniques, that is no magnetic media or moving parts are employed. Both devices are powered by alkaline batteries and have no AC power connection.
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