Clearance Summary
MODEL 10200 PREMATURE INFANT INCUBATOR received FDA 510(k) clearance under submission number K862921, sponsored by Rotem Industries C/O Medsys, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1987-04-01.
- Submission: K862921
- Applicant / Sponsor: Rotem Industries C/O Medsys, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5130
- Decision date: 1987-04-01
Classification & Regulation
This clearance is catalogued under FDA product code FMT and 21 CFR 880.5130, within the General Hospital review panel as a Class II device.