510(k) K162821
K162821 is an FDA 510(k) premarket notification submitted by Draegerwerk AG & CO Kgaa for the device "Babyleo TN500". The FDA issued a decision of Substantially Equivalent on June 23, 2017. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Draegerwerk AG & CO Kgaa has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 2017
- Date Received
- October 7, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Incubator, Neonatal
- Device Class
- Class II
- Regulation Number
- 880.5400
- Review Panel
- HO
- Submission Type