Clearance Summary
Maximus System received FDA 510(k) clearance under submission number K200988, sponsored by Hill-Rom Services Pte, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2020-05-26.
- Submission: K200988
- Applicant / Sponsor: Hill-Rom Services Pte, Ltd.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2020-05-26
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.