Satcare Oxygen Controller/Monitor W/ Pulse Oximete

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K924709 ↗

FDA Product Code

KLK

Device Class

Class II

Regulation

21 CFR Part 868.2500

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Air-Shields, Inc. →

• What is the Satcare Oxygen Controller/Monitor used for?

  The Satcare Oxygen Controller/Monitor is used to monitor oxygen levels in patients, particularly in anesthesiology settings.

• Is the Satcare Oxygen Controller/Monitor a single-use or reusable device?

  The device description does not specify whether it is single-use or reusable, but it is classified as a Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia.

• What is the product code for the Satcare Oxygen Controller/Monitor?

  The product code for the Satcare Oxygen Controller/Monitor is KLK, with a regulation number of 868.2500.

• What medical specialty is the Satcare Oxygen Controller/Monitor intended for?

  The Satcare Oxygen Controller/Monitor is intended for use in anesthesiology, with a medical specialty description of Anesthesiology.