Deltatrac Metabolic Monitor

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

Full name

Deltatrac(Tm) Metabolic Monitor

510(k) Number

K864603 ↗

FDA Product Code

BZL

Device Class

Class II

Regulation

21 CFR Part 868.1730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Datex Division Instrumentarium Corp. →

• What is the Deltatrac Metabolic Monitor used for?

  The Deltatrac Metabolic Monitor is a computer-based device designed to measure oxygen uptake in medical settings. It is specifically intended for monitoring metabolic functions, particularly in anesthesiology settings where precise oxygen measurement is critical for patient care.

• How is the Deltatrac Metabolic Monitor supplied?

  The device is supplied with various model numbers including K864603 and K931422. It is manufactured by Datex Division Instrumentarium Corp. and comes as a complete system for measuring oxygen uptake in clinical environments.

• What is the regulatory status of the Deltatrac Metabolic Monitor?

  The Deltatrac Metabolic Monitor has FDA 510(k) clearance with product code BZL. It is classified as a Class II device under special controls, with the clearance granted on March 17, 1987, after being received on November 24, 1986.

• In what medical settings is the Deltatrac Metabolic Monitor typically used?

  The Deltatrac Metabolic Monitor is primarily used in anesthesiology settings where monitoring metabolic functions and oxygen uptake is essential. It is designed for medical environments where precise measurement of oxygen consumption is required for patient assessment and care.