SFP — Ventilator-Compatible Nebulizer Class II
FDA product code SFP covers "Ventilator-Compatible Nebulizer", a Class II medical device regulated under 21 CFR 868.5630. Submissions are reviewed by the Anesthesiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SFP
- Device Class
- Class II
- Regulation Number
- 868.5630
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
The device is intended to deliver nebulized medications through a ventilator breathing circuit.