EZ-1 System Respiratory Effort Sensors

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

510(k) Number

K913395 ↗

FDA Product Code

BZG

Device Class

Class II

Regulation

21 CFR Part 868.1840

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• What is the EZ-1 System Respiratory Effort Sensors used for?

  The EZ-1 System Respiratory Effort Sensors is designed to measure respiratory effort and is intended for use in the field of anesthesiology as a diagnostic spirometer.

• How is the EZ-1 System Respiratory Effort Sensors supplied or configured for use?

  The device is supplied as a complete system for measuring respiratory effort, though specific components or accessories are not detailed in the provided data; it is intended for clinical use in anesthesiology settings.

• Is the EZ-1 System Respiratory Effort Sensors reusable or single-use?

  The provided data does not specify whether the EZ-1 System Respiratory Effort Sensors is reusable or single-use; users should consult the manufacturer's labeling for reprocessing or disposal instructions.

• What regulatory pathway was used for the EZ-1 System Respiratory Effort Sensors?

  The EZ-1 System Respiratory Effort Sensors received traditional 510(k) clearance (K913395) from the FDA on May 20, 1992, and was determined to be substantially equivalent to a predicate device.

• What classification and product code apply to the EZ-1 System Respiratory Effort Sensors?

  The device is classified as a Class II medical device under product code BZG and regulation number 868.1840, with a diagnostic spirometer designation in the anesthesiology specialty.