Cam 4 Thermoelectric Child/Adult Mist Tent

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

510(k) Number

K941547 ↗

FDA Product Code

BYK

Device Class

Class II

Regulation

21 CFR Part 868.5710

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Allied Healthcare Products, Inc. →

• What is the primary function of the Cam 4 Thermoelectric Mist Tent?

  This device is an electrically powered oxygen tent designed to create a controlled environment for patients. It uses thermoelectric cooling technology to maintain the internal atmosphere while simultaneously facilitating the administration of aerosol therapy.

• Which patient populations is this mist tent intended for?

  The Cam 4 Thermoelectric Mist Tent is designed for versatility and is intended for use with both children and adults requiring a controlled oxygen or aerosol environment.

• What is the regulatory status of this device?

  The device is regulated as a Class 2 medical device under regulation number 868.5710. It has received FDA 510k clearance under K-number K941547, confirming it is substantially equivalent to predicate devices.