CS/3(TM) MONITORS*

K974792 · Datex-Engstrom, Inc. · DSI · Jun 2, 1998 · Cardiovascular

Device Facts

• Record ID: K974792
• Device Name: CS/3(TM) MONITORS*
• Applicant: Datex-Engstrom, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Jun 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The CS/3TMMonitors are indicated for multiparameter patient monitoring in all hospital patients.

Device Story

CS/3 Monitors (Critical Care and Compact models) provide multiparameter patient monitoring in hospital settings. Device collects physiological data from patients; processes signals to display real-time clinical parameters; assists clinicians in patient status assessment and decision-making. Intended for use by healthcare professionals in hospital environments.

Technological Characteristics

Multiparameter patient monitoring system; includes Critical Care and Compact monitor configurations.

Indications for Use

Indicated for multiparameter patient monitoring in all hospital patients.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1998

Mr. Joel C. Kent Datex Engstrom, Inc. 3 Highwood Drive Tewksbury, MA 01876

Re: K974792 CS/3™ Monitors* Regulatory Class: III (three) Product Code: 74 DSI Dated: March 12, 1998 Received: March 13, 1998

Dear Mr. Kent:

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 requlations affecting your device can be found in the Code of Federal Requlations, 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 Failure to comply with the GMP regulation may result in assumptions. 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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Psge 2 - Mr. Joel C. Kent

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 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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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K974792 510(k) Number (if known): _

CS/3TMMonitors* Device Name: _

* Includes CS/3TM Critical Care Monitor and CS/3TM Compact Monitor.

Indications For Use:

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The CS/3TMMonitors are indicated for multiparameter patient monitoring in all hospital patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

Danielle

人才能在线上

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_14974792