TED 60T OXYGEN ANALYZER

K990457 · Teledyne Electronic Technologies · CCL · Nov 9, 1999 · Anesthesiology

Device Facts

• Record ID: K990457
• Device Name: TED 60T OXYGEN ANALYZER
• Applicant: Teledyne Electronic Technologies
• Product Code: CCL · Anesthesiology
• Decision Date: Nov 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TED 60T is intended to accurately measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and neonatal care. The TED 60T is intended for use only as a secondary measuring device to verify and spot check the concentration of oxygen in gas mixtures. The TED 60T should not be used as a primary monitoring device.

Device Story

The TED 60T is a portable oxygen analyzer used in clinical settings like anesthesia, respiratory therapy, and neonatal care. It functions as a secondary measuring device for spot-checking oxygen concentrations in gas mixtures. It is not intended for use as a primary monitoring device. The device takes gas samples as input, processes the concentration levels, and displays the oxygen percentage to the clinician. It assists healthcare providers in verifying gas mixture accuracy, thereby supporting clinical decision-making regarding patient respiratory support. It is operated by clinicians to ensure the safety and accuracy of delivered gas mixtures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Oxygen analyzer for gas mixtures; secondary measurement/spot-check functionality; portable form factor; intended for clinical use in anesthesia, respiratory therapy, and neonatal care.

Indications for Use

Indicated for use in anesthesia, respiratory therapy, and neonatal care settings for secondary verification and spot-checking of oxygen concentration in gas mixtures.

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

NOV - 9 1999

Mr. Ray Khajavi Teledyne Electronic Technologies Analytical Instruments 16830 Chestnut Street City of Industry, CA 91749-1580

- K990457 Re: Ted 60T Oxygen Analyzer Regulatory Class: II (two) Product Code: 73 CCL Dated: Auqust 10, 1999 Received: August 11, 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 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, 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 aqainst 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 A substantially equivalent determination assumes compliance to 895. 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. requlatory 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" (21CFR 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,

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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 60T Indications for Use

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## 510(k) Number:

The TED 60T is intended to accurately measure and display the concentration of oxygen in gas mixtures used in medical applications such as anesthesia, respiratory therapy, and neonatal care. The TED 60T is intended for use only as a secondary measuring device to verify and spot check the concentration of oxygen in gas mixtures. The TED 60T should not be used as a primary monitoring device.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use &

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Over the Counter Use

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