Clearance Summary
MetaNeb 4 System received FDA 510(k) clearance under submission number K151689, sponsored by Hill-Rom Services Pte, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2016-03-17.
- Submission: K151689
- Applicant / Sponsor: Hill-Rom Services Pte, Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2016-03-17
Classification & Regulation
This clearance is catalogued under FDA product code NHJ and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.