Monitor, Resp. Oxygen (Top)

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

510(k) Number

K760338 ↗

FDA Product Code

CCL

Device Class

Class II

Regulation

21 CFR Part 868.1720

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• What is the Oxygen Monitor Top used for?

  The Oxygen Monitor Top is used to monitor respiratory oxygen levels in a clinical setting, specifically in the medical specialty of Anesthesiology.

• Is the Oxygen Monitor Top supplied as a single unit?

  Yes, the Oxygen Monitor Top is supplied as a single unit, intended for use in a clinical setting.

• What is the regulatory classification of the Oxygen Monitor Top?

  The Oxygen Monitor Top is classified under the regulation number 868.1720 and has a product code of CCL, and has been found to be substantially equivalent by the FDA.