TED 200T7 OXYGEN MONITOR

K990403 · Teledyne Electronic Technologies · CCL · Feb 3, 2000 · Anesthesiology

Device Facts

• Record ID: K990403
• Device Name: TED 200T7 OXYGEN MONITOR
• Applicant: Teledyne Electronic Technologies
• Product Code: CCL · Anesthesiology
• Decision Date: Feb 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TED 200T7 is intended to continuously measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.

Device Story

The TED 200T7 is an oxygen monitor designed for continuous measurement and display of oxygen concentration in gas mixtures. It is utilized in clinical environments such as anesthesia and respiratory therapy. The device processes input from gas mixtures to provide real-time oxygen concentration readings, allowing clinicians to monitor patient respiratory status. It is intended for use across adult, pediatric, and neonatal patient populations. The output is displayed for healthcare providers to facilitate clinical decision-making regarding oxygen delivery and patient ventilation, ultimately aiming to ensure appropriate oxygenation levels during medical procedures or therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oxygen monitor for gas mixtures; continuous measurement and display functionality; intended for clinical use in anesthesia and respiratory therapy; supports adult, pediatric, and neonatal applications.

Indications for Use

Indicated for continuous oxygen concentration measurement in gas mixtures for adult, pediatric, and neonatal patients in anesthesia and respiratory therapy settings.

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

FEB 3 2000

Mr. Ray Khajavi Teledyne Electronic Technologies 16830 Chestnut Street City of Industry, CA 91748-1020

Re : K990403 Ted 200T7 Oxygen Monitor Regulatory Class: II (two) 73 CCL Product Code: November 5, 1999 Dated: Received: November 8, 1999

Dear Mr. Khajavi:

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 requlation 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. Ray Khajavi

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/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## TED 200T7 Indications for Use

## 510(k) Number:

The TED 200T7 is intended to continuously measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and is intended for adult, pediatric and neonatal populations.

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

## Over the Counter Use

(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _K950403