510(k) K251619
K251619 is an FDA 510(k) premarket notification submitted by Drägerwerk AG & Co. KGaA for the device "Babyleo TN500". The FDA issued a decision of Substantially Equivalent on February 13, 2026. The device falls under product code FMZ (Incubator, Neonatal), a Class II device regulated under 21 CFR 880.5400. Drägerwerk AG & Co. KGaA has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2026
- Date Received
- May 27, 2025
- 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