Emerson Cough Assist Model Ca-3000 W/Automatic Timing and Model Cm-3000 W/Manual Timing

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K002598 ↗

FDA Product Code

NHJ

Models / Variants

Ca-3000 W

Automatic Timing

Model Cm-3000 W

Manual Timing

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• What is the Emerson Cough Assist device used for?

  The Emerson Cough Assist is a positive pressure breathing device designed to assist patients with coughing. It is available in two models: CA-3000 with automatic timing mechanisms and CM-3000 with manually operated valve for controlling inspiratory and expiratory cycles.

• How are the Emerson Cough Assist devices supplied?

  These devices are supplied for use in clinical settings and are regulated as Class II medical devices with FDA 510K clearance. They are intended for anesthesiology applications and require proper storage and handling according to the manufacturer's guidelines.

• What models are available in the Emerson Cough Assist series?

  The Emerson Cough Assist series includes multiple models: CA-3000 with automatic timing, CA-3200, CM-3000 with manual timing, and CM-3200. Each model has specific features that vary, with the CA-3000 and CM-3000 being the primary models described in this device data.

• What is the regulatory status of the Emerson Cough Assist devices?

  The Emerson Cough Assist devices are regulated as Class II medical devices with FDA 510K clearance. They were filed under the product code NHJ and reviewed by the Anesthesiology advisory committee, with a decision of 'Substantially Equivalent' in 2000.