SDS — Compression-Based Airway Clearance Device Class II
FDA product code SDS covers "Compression-Based Airway Clearance Device", a Class II medical device regulated under 21 CFR 868.5665. Submissions are reviewed by the Anesthesiology panel.
Classification Details
- Product Code
- SDS
- Device Class
- Class II
- Regulation Number
- 868.5665
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
It is intended to support bronchial drainage breathing techniques by providing oscillating regional compression to the thorax.