CARDIOPHONICS 1000 MEMORY MONITOR

K992772 · Rlt Medical Assoc., Inc. · DXH · Sep 17, 1999 · Cardiovascular

Device Facts

• Record ID: K992772
• Device Name: CARDIOPHONICS 1000 MEMORY MONITOR
• Applicant: Rlt Medical Assoc., Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Sep 17, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

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.

Device Story

Cardiophonics 1000 is a two-channel cardiac event recorder; captures ECG signals via electrodes; utilizes microprocessor and analog-to-digital conversion to store data in a memory loop. Device transmits stored ECG data over analog phone lines or RS-232 serial port to a PC receiving station. Configured via onboard keys or PC software. Used by patients for event recording; data reviewed by healthcare professionals to assist in cardiac diagnosis and clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and intended use comparison to predicate device.

Technological Characteristics

Two-channel cardiac event recorder; microprocessor-based; analog-to-digital conversion circuits; memory loop storage; connectivity via analog phone line and RS-232 serial port; PC-based software interface.

Indications for Use

Indicated for patients requiring cardiac event monitoring; records two-channel ECG data for review by healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• Cardiophonics Memory Transmitter (K934975)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 17 1999

Mr. Richard L. Trader President RLT Medical Associates, Inc. 9620 Deereco Road Timonium, MD 21093

K992772 Re: Cardiophonics 1000 Memory Monitor Regulatory Class: II (two) Product Code: 74DXH Dated: August 16, 1999 August 18, 1999 Received:

Dear Mr. Trader:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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## Page 2 - Mr. Richard L. Trader

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
Stuart Holkoy

Thomas J. C Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 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 }

Nare Rallucy MD. for DBT
(Division Sign-Off)
9-16-99

(Division of Cardiov and Neurological De 510(k) Number