Clearance Summary
Babyleo TN500 received FDA 510(k) clearance under submission number K162821, sponsored by Draegerwerk AG & CO Kgaa. 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 2017-06-23.
- Submission: K162821
- Applicant / Sponsor: Draegerwerk AG & CO Kgaa
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5400
- Decision date: 2017-06-23
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.