ECG MINIMONITOR, MODEL CG-5000

K992696 · Card Guard Scientific Survival , Ltd. · DXH · Oct 7, 1999 · Cardiovascular

Device Facts

• Record ID: K992696
• Device Name: ECG MINIMONITOR, MODEL CG-5000
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Oct 7, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

CG-5000 ECG MiniMonitor is a medical device intended for recording, display, output to the electrocardiograph recorder, and, optionally, transtelephonic transmission of the ECG signal for the purpose of cardiac conditions analysis.

Device Story

CG-5000 ECG MiniMonitor records and displays ECG signals; optionally transmits signals transtelephonically for cardiac analysis. Used by clinicians or patients in clinical or home settings to monitor cardiac conditions. Device outputs ECG data to recorders or remote analysis systems. Healthcare providers use output to assess cardiac health and inform clinical decisions. Benefits include remote monitoring capability and diagnostic support for cardiac conditions.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) notification review.

Technological Characteristics

ECG monitoring device; performs signal recording, display, and transtelephonic transmission. Class II device.

Indications for Use

Indicated for patients requiring ECG signal recording, display, and transtelephonic transmission for cardiac condition analysis. Prescription use only.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 1999 ОСТ

Mr. Leonid Trachtenberg Chief Engineer Card Guard Scientific Survival Ltd. 2 Pekeris Street, P.O.B. 527 Rehovot 76100 ISRAEL

K992696 Re: ECG Minimonitor, Model CG-5000 Regulatory Class: II (two) Product Code: 74 DXH Dated: August 26, 1999 Received: August 30, 1999

Dear Mr. Trachtenberg:

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, good 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 requlations 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 regulations.

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## Page 2 - Mr. Leonid Trachtenberg

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,

Sincerely yours,

Thomas J. Callehan

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

Enclosure

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**CARD GUARD**
Scientific Survival LTD

Page 1 of 1

**510(k) Number:** K992696

Device Name: Card Guard Model CG-5000 ECG MiniMonitor

## Indications For Use:

CG-5000 ECG MiniMonitor is a medical device intended for recording, display, output to the electrocardiograph recorder, and, optionally, transtelephonic transmission of the ECG signal for the purpose of cardiac conditions analysis.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Omer L. Goode for DBT

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K992696

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)