CARDIOPHONICS 1000 MEMORY MONITOR

• K Number: K992772
• Device Name: CARDIOPHONICS 1000 MEMORY MONITOR
• Manufacturer: RLT MEDICAL ASSOC., INC.
• Date Cleared: 1999-09-17 ( 30 days)
• Product Code: DXH , 74D
• Regulation Number: 870.2920
• Type: Special
• Panel: CV
• Reference & Predicate Devices: K934975
• Predicate For: N/A

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.

AI/ML Overview

This document is an FDA 510(k) clearance letter for the Cardiophonics 1000 Memory Monitor. It does not contain the specific details of acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information from the provided text. The document confirms that the device is substantially equivalent to a predicate device, but it doesn't describe the performance studies that led to that determination.

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).