CARD GUARD, MODEL CG-6550

K990478 · Card Guard Scientific Survival , Ltd. · DXH · Aug 31, 1999 · Cardiovascular

Device Facts

• Record ID: K990478
• Device Name: CARD GUARD, MODEL CG-6550
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Aug 31, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The CG-6550 is a Personal 3-Lead Electrocardiogram (ECG) Transmitter intended for long-term monitoring of cardiac patients, for detection of rhythm disorders and ST-changes.

Device Story

Card Guard Model CG-6550 is a personal 3-lead ECG transmitter designed for long-term cardiac monitoring. The device captures ECG signals from the patient and transmits them for remote analysis. It is intended for use by cardiac patients to detect rhythm disorders and ST-segment changes. The system facilitates remote monitoring, allowing healthcare providers to review transmitted data to inform clinical decision-making regarding cardiac health. The device supports ongoing patient management outside of clinical settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Personal 3-lead ECG transmitter; portable form factor; intended for long-term monitoring; transmits cardiac signal data.

Indications for Use

Indicated for long-term monitoring of cardiac patients for the detection of rhythm disorders and ST-segment changes.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 31 1999

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

Re: K990478 Card Guard Personal ECG Transmitter Model CG-6550 Regulatory Class: II (two) Product Code: 74 DXH Dated: June 6, 1999 Received: June 8, 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 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 requlation (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 requlatory 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"(21 CFR 807.97). Other qeneral 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. Callahan, Ph.D.

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.

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510(k) Number :

Device Name: Card Guard Model CG-6550 Personal 3-Lead ECG Transmitter.

Indication For Use:

The CG-6550 is a Personal 3-Lead Electrocardiogram (ECG) Transmitter intended for long-term monitoring of cardiac patients, for detection of rhythm disorders and ST-changes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Den Th. Miller

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

Prescription Use
(Per 21 CFR 801.109)

ﺎﻧﻌ

OR

Over-The-Counter Use

(Optional Format 1-2-96)