PRO2 CHECK OXYGEN INDICATOR

K983500 · Medical Technology Specialists, Inc. · CCL · Mar 17, 1999 · Anesthesiology

Device Facts

• Record ID: K983500
• Device Name: PRO2 CHECK OXYGEN INDICATOR
• Applicant: Medical Technology Specialists, Inc.
• Product Code: CCL · Anesthesiology
• Decision Date: Mar 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1720
• Device Class: Class 2

Device Story

The PRO2 Check Oxygen Indicator is a device used to monitor oxygen levels. It functions as an indicator for oxygen concentration. The device is intended for use in clinical or similar settings to provide information regarding oxygen delivery. It operates by measuring oxygen levels and providing an output to the user, which assists healthcare providers in assessing oxygenation status. The device is designed to be used by trained personnel to ensure appropriate oxygen administration, potentially benefiting patients by helping to maintain proper oxygen levels during therapy.

Technological Characteristics

The device is an oxygen indicator classified under 21 CFR Part 800-895. It is a Class II device (Product Code 73). No specific materials, sensing principles, or software details are provided in the document.

Regulatory Classification

Identification

An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 22 1999

Mr. Donald W. Morrow, III Medical Technology Specialists 6290-D Warwick Road Richmond, VA 23224

Re: K983500 PRO2 Check Oxygen Indicator Regulatory Class: II (two) Product Code: 73 CCL Dated: February 25, 1999 Received: February 26, 1999

Dear Mr. Morrow:

This letter corrects our substantially equivalent letter of March 17, 1999, regarding the error in your 510(k) number.

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 leqally 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 requlations 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 further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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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.

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 [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/dsma/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