510(k) K251615
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2025
- Date Received
- May 27, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator-Compatible Nebulizer
- Device Class
- Class II
- Regulation Number
- 868.5630
- Review Panel
- AN
- Submission Type
The device is intended to deliver nebulized medications through a ventilator breathing circuit.