← Product Code LOS · K970879

# CARDIOVIT CS-200 (K970879)

_Schiller America, Inc. · LOS · Jun 25, 1997 · CV · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K970879

## Device Facts

- **Applicant:** Schiller America, Inc.
- **Product Code:** LOS
- **Decision Date:** Jun 25, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Review Panel:** CV

## Intended Use

The Cardiovit CS-200 device may be used to record and store standard 12 lead Electrocardiograms (ECG) at patients resting or exercising. Resting ECG's are automatically measured and interpreted by the optionally available Schiller ECG interpretation program.

## Device Story

Cardiovit CS-200 records and stores 12-lead ECG signals from patients during rest or exercise. Device includes optional software for automated measurement and interpretation of resting ECGs. Used in clinical settings by healthcare professionals. Output provides ECG waveforms and automated analysis to assist clinicians in cardiac assessment and diagnostic decision-making.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

12-lead ECG acquisition system. Includes optional software module for automated ECG measurement and interpretation. Connectivity and hardware specifications not detailed.

## Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Markus Maritz
Schiller America, Inc.
3002 Dow Avenue
Building 138
Tustin, California 92780

Re: K970879
Cardiovit CS-200
Regulatory Class: III (three)
Product Code: 74 LOS
Dated: June 5, 1997
Received: June 9, 1997

Dear Mr. Maritz:

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, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. Markus Maritz

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) 594-4646. 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 regulation 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,

![img-0.jpeg](img-0.jpeg)

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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05/29/97 13:17 301 827 4351 DHHS FDA DCRND 001

Page 1 of 1

510(k) Number (if known): K970879

Device Name: Cardiovit CS-200

Indications For Use:

The Cardiovit CS-200 device may be used to record and store standard 12 lead Electrocardiograms (ECG) at patients resting or exercising. Resting ECG's are automatically measured and interpreted by the optionally available Schiller ECG interpretation program.

9 Jun 97 12 32
FDA/CDRH/ODE/DHC
RECEIVED

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

E. D. (Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970879

Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐

(Optional Format 1-2-96)

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