Spirolite Model MSC-201 Spirometer

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

510(k) Number

K921513 ↗

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 clinical settings is the Spirolite Model MSC-201 Spirometer intended for use in?

  The Spirolite Model MSC-201 Spirometer is designed for clinical use in environments like hospitals, physician offices, and pulmonary function laboratories. Its purpose is to evaluate respiratory health by measuring lung function parameters such as forced vital capacity, forced expiratory volume, and peak expiratory flow.

• Is the Spirolite Model MSC-201 Spirometer a single-use or reusable device?

  The Spirolite Model MSC-201 Spirometer is a reusable device. To maintain accuracy and ensure sterility, it requires proper cleaning and maintenance as part of its clinical use.

• What regulatory pathway was followed for FDA clearance of the Spirolite Model MSC-201 Spirometer?

  The Spirolite Model MSC-201 Spirometer received FDA 510(k) clearance through a traditional review process, with the device classified under the product code BZG and regulated under regulation number 868.1840. The clearance was determined to be substantially equivalent, and the decision was made by the Anesthesiology (AN) Advisory Committee on January 27, 1993.

• Are there any specific storage requirements mentioned for the Spirolite Model MSC-201 Spirometer?

  The provided data does not explicitly detail storage requirements for the Spirolite Model MSC-201 Spirometer. However, since it is a reusable device, proper handling and maintenance procedures should be followed to preserve its functionality and ensure accurate measurements.