← Product Code [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN) · K972795

# CARDIO-CARD MANAGEMENT SYSTEM II (K972795)

_Nasiff Assoc., Inc. · DXN · Feb 20, 1998 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN/K972795

## Device Facts

- **Applicant:** Nasiff Assoc., Inc.
- **Product Code:** [DXN](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXN.md)
- **Decision Date:** Feb 20, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1130
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Intended Use

The Cardio-Card system monitors heart mythms and reports ECGs, thythm conditions, ECG printouts, BCG measurements, NIBPs and patient demographic information (e.g. patient name, ssn, physician name, address, physician notes, test notes). The system stores the patient's data to computers for later easy retrieval from its database. The computers can be networked to allow sharing of the information also. Studies can be typical short 12-sec ECG strips and NIBPs or very long term studies.

## Device Story

Cardio-Card Management System II monitors heart rhythms, ECGs, and NIBPs; inputs include physiological signals and patient demographic data. System stores data in a computer database for retrieval and networking. Used in clinical settings by healthcare providers to review ECG strips, rhythm conditions, and measurements. Output facilitates clinical decision-making by providing organized patient records and diagnostic data for review. Benefits include efficient data management and long-term monitoring capabilities.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Computer-based system for ECG and NIBP monitoring; supports networking for data sharing; database storage for patient demographics and test results.

## Regulatory Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

## Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing the wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Roger E. Nasiff President Nasiff Associates, Inc. P.O. Box 88 Brewerton, NY 13029

FEB 2 0 1998

Re : K972795 Cardio-Card Management System II II (Two) Requlatory Class: Product Code: 74 DXN Dated: November 21, 1997 ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Received: November 24, 1997

Dear Mr. Nasiff:

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 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, Druq, 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 obliqation 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. Roger E. Nasiff

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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

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

Enclosure

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Page I of 1

发生 - 2017-04-04

510(k) Number (if known): 长972795

Device Name: Cardio-Card Management System II

Indications For Use:

. ·

The Cardio-Card system monitors heart mythms and reports ECGs, thythm conditions, ECG printouts, BCG measurements, NIBPs and patient demographic information (e.g. patient name, ssn, physician name, address, physician notes, test notes). The system stores the patient's data to computers for later easy retrieval from its database. The computers can be networked to allow sharing of the information also. Studies can be typical short 12-sec ECG strips and NIBPs or very long term studies.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*[Signature]*

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

| 510(k) Number                         |    |                      |
|---------------------------------------|----|----------------------|
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |

(Optional Format 1-2-96)

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