CG-3250 MINIRECEIVER

K012187 · Card Guard Scientific Survival , Ltd. · DXH · Aug 14, 2001 · Cardiovascular

Device Facts

• Record ID: K012187
• Device Name: CG-3250 MINIRECEIVER
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Aug 14, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The device is intended for receiving the signal, transmitted by the Card Guard personal transtelephonic transmitters and transferring the signal to PC equipped with the TM2000 Receiving program or compatible.

Device Story

CG-3250 MiniReceiver acts as a signal interface; receives transtelephonic signals from Card Guard personal transmitters; transfers data to a PC running TM2000 receiving software. Used in clinical settings or remote monitoring environments; operated by healthcare professionals or trained staff. Device facilitates the transmission of physiological data (e.g., ECG) from patient-worn transmitters to a central receiving station. Healthcare providers use the PC-based output to review patient signals, supporting clinical decision-making regarding cardiac status. Benefits include enabling remote patient monitoring and timely access to diagnostic data.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Signal receiver for transtelephonic transmission; interfaces with PC via TM2000 software; standalone hardware component; operates as a data bridge between personal transmitters and receiving stations.

Indications for Use

Indicated for receiving and transferring transtelephonic signals from Card Guard transmitters to a PC running TM2000 software for clinical monitoring purposes.

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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AUG 1 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Leonid Trachtenberg Chief Engineer Card Guard Scientific Survival, Ltd. 2 Pekeris Street. Science Park Rehovot ISRAEL

Re: K012187

Trade Name: CG-3250 TM MiniReceiver Regulation Number: 21 CFR 870.2920 Regulatory Class: II (two) Product Code: 74 DXH Dated: July 26, 2001 Received: July 30, 2001

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 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

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## Page 2 - Mr. Leonid Trachtenberg

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 Itsponse to your promation nouncears the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 noutheation. The I Drivening as fication 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 additionally 607.10 for mi mi mo and advertising on the promotion and advertising of your device, (2017) 594-1010. Traditional [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 mionination on your responsibility the number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Souda Tille

ames E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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**CARD GUARD**
Scientific Survival LTD

K012187

The device is intended for receiving the signal, transmitted by the Card Guard personal transtelephonic transmitters and transferring the signal to PC equipped with the TM2000 Receiving program or compatible.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K01287