SDT — Intra-Pulmonary Percussive Vibration (Ipv) Devices Class II
FDA product code SDT covers "Intra-Pulmonary Percussive Vibration (Ipv) Devices", a Class II medical device regulated under 21 CFR 868.5665. Submissions are reviewed by the Anesthesiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SDT
- Device Class
- Class II
- Regulation Number
- 868.5665
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.