Model 7000 Combination End Tidal & Pulse Oximetry

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K874036 ↗

FDA Product Code

CCK

Device Class

Class II

Regulation

21 CFR Part 868.1400

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Novametrix Model 510

  Class II

  FDA 510(k) K924626 Active Cleared 3 Dec 1993

• Novametrix Tcomette #809 Trans. Monitor

  Class II

  FDA 510(k) K800988 Active Cleared 28 May 1980

• TC02 M Oxygen Electrode Contact

  Class II

  FDA 510(k) K792009 Active Cleared 26 Oct 1979

• Model 1010 Physiological Signal Telemetry Monitor

  Class II

  FDA 510(k) K873672 Active Cleared 3 Dec 1987

• TC02M Electrode Adhesive Rings

  Class II

  FDA 510(k) K792010 Active Cleared 26 Oct 1979

• Novatracer Recorder

  Class I

  FDA 510(k) K811453 Active Cleared 10 Jul 1981

See all devices from Novametrix Medical Systems, Inc. →

• What is the Model 7000 Combination End Tidal & Pulse Oximetry used for?

  The Model 7000 Combination End Tidal & Pulse Oximetry is designed to measure end-tidal carbon dioxide and oxygen saturation levels in patients. It combines both end-tidal gas monitoring and pulse oximetry functions into a single device for respiratory and oxygenation assessment.

• Who manufactures the Model 7000 Combination End Tidal & Pulse Oximetry?

  The Model 7000 Combination End Tidal & Pulse Oximetry is manufactured by Novametrix Medical Systems, Inc., located at 1 Barnes Industrial Park Rd., P.O. Box 690, Wallingford, CT 06492, United States. The applicant listed in the FDA 510(k) submission is Novametrix Medical Systems, Inc., with contact person Robert E. Yocher.

• How was the Model 7000 Combination End Tidal & Pulse Oximetry cleared for market?

  The Model 7000 Combination End Tidal & Pulse Oximetry was cleared through the FDA 510(k) process under submission K874036. It received a traditional clearance type with a decision of 'Substantially Equivalent' on November 6, 1987, following an advisory committee review in anesthesiology.

• What product code and advisory committee apply to the Model 7000 Combination End Tidal & Pulse Oximetry?

  The Model 7000 Combination End Tidal & Pulse Oximetry is classified under product code CCK and was reviewed by the anesthesiology advisory committee (AN). This classification reflects its intended use in monitoring respiratory parameters during anesthesia care.