Turboaire Challanger Environmental Air Controller

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K843996 ↗

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 Turboaire Challanger Environmental Air Controller used for?

  The Turboaire Challanger Environmental Air Controller is designed to control environmental air in medical settings, specifically related to anesthesiology applications. It helps maintain proper air quality and conditions during medical procedures.

• What is the regulatory status of this device?

  The Turboaire Challanger Environmental Air Controller is FDA 510(k) cleared with K number K843996. It is classified as a Class II medical device under product code BZG and regulated under 21 CFR 868.1840.

• Who manufactures the Turboaire Challanger Environmental Air Controller?

  The device is manufactured by Equilibrated Bio Systems, Inc., located at 900 Walt Whitman Rd., Melville, NY 11747. It was FDA cleared on November 20, 1984.

• What advisory committee reviewed this device?

  The Turboaire Challanger Environmental Air Controller was reviewed by the Anesthesiology advisory committee (AN), which specializes in evaluating devices related to anesthesiology applications and patient care in this medical field.