Normac Anesthetic Agent Monitor

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

510(k) Number

K832113 ↗

FDA Product Code

CBS

Device Class

Class II

Regulation

21 CFR Part 868.1620

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Datex Division Instrumentarium Corp. →

• What is the Normac Anesthetic Agent Monitor used for?

  The Normac Anesthetic Agent Monitor is designed to measure the concentration of anesthetic agents in the gaseous phase, specifically for monitoring halothane, isoflurane, and enflurane concentrations during anesthesia procedures.

• Is the Normac Anesthetic Agent Monitor single-use or reusable?

  The device data does not specify whether the Normac Anesthetic Agent Monitor is single-use or reusable. No information regarding sterility or MRI safety is provided in the available data.

• What is the regulatory status of the Normac Anesthetic Agent Monitor?

  The Normac Anesthetic Agent Monitor is a Class II medical device with FDA 510(k) clearance, registered under product code CBS. It received FDA clearance on September 12, 1983, with K number K832113.

• How is the Normac Anesthetic Agent Monitor supplied?

  The Normac Anesthetic Agent Monitor is supplied by Datex Division Instrumentarium Corp. and is intended for use in anesthesia settings. No specific information about packaging or supply configurations is provided in the device data.