Clearance Summary
Isolette 8000 Plus received FDA 510(k) clearance under submission number K182977, sponsored by Draeger Medical Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2018-11-21.
- Submission: K182977
- Applicant / Sponsor: Draeger Medical Systems, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5400
- Decision date: 2018-11-21
Classification & Regulation
This clearance is catalogued under FDA product code FMZ and 21 CFR 880.5400, within the General Hospital review panel as a Class II device.