Product code SFP
- Device name
- Ventilator-Compatible Nebulizer
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5630
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- The device is intended to deliver nebulized medications through a ventilator breathing circuit.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K251584 | Medical Mesh Nebulizer (AirICU Max+) | AIRICU, Inc. | 2026-03-12 |
| K251615 | Aerogen Pro-X1 Controller System | Aerogen, Ltd. | 2025-09-02 |