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510(k) Data Aggregation
K Number
K992772Device Name
CARDIOPHONICS 1000 MEMORY MONITOR
Manufacturer
Date Cleared
1999-09-17
(30 days)
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
RLT MEDICAL ASSOC., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cardiophonics memory transmitter is a two-channel cardiac event recorder. It incorporates a microprocessor and analog to digital conversion circuits. This allows the unit to store ECG data in a memory loop configuration. This ECG data is then sent over a analog phone line or RS-232 serial port for display by a PC receiving station. The monitor may be configured and programmed either by the program keys on the monitor or by the PC Cardiophonics 1000 software program. All data is then reviewed by a health professional.
This is the same intended use and purpose as previously cleared for the Cardiophonics Memory Transmitter. { 510K K934975 }
Device Description
The Cardiophonics memory transmitter is a two-channel cardiac event recorder. It incorporates a microprocessor and analog to digital conversion circuits. This allows the unit to store ECG data in a memory loop configuration. This ECG data is then sent over a analog phone line or RS-232 serial port for display by a PC receiving station. The monitor may be configured and programmed either by the program keys on the monitor or by the PC Cardiophonics 1000 software program.
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