Dymedix Reusable Airflow/Snore Sensor

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K040069 ↗

FDA Product Code

MNR

Device Class

Class II

Regulation

21 CFR Part 868.2375

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Respiratory Belt Sensor, Model 6000S; Limb Movement Sensor, Model 3000S

  Class II

  FDA 510(k) K001030 Active Cleared 11 May 2000

• Chin Electrode

  Class II

  FDA 510(k) K020468 Active Cleared 16 Apr 2002

• Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb Movement Sensor, Model 3100

  Class II

  FDA 510(k) K040605 Active Cleared 26 Apr 2004