Babyleo TN500
K-Number: K251619 · 2026-02-13
ApplicantDrägerwerk AG & Co. KGaA
Decision Date2026-02-13
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Babyleo TN500 is a medical device manufactured by Drägerwerk AG & Co. KGaA. It received FDA 510(k) clearance on 2026-02-13 under approval number K251619. The device is classified under product code FMZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Babyleo TN500?
Babyleo TN500 is a medical device that received FDA 510(k) clearance on 2026-02-13. It is manufactured by Drägerwerk AG & Co. KGaA. The 510(k) number is K251619.
When was Babyleo TN500 approved by the FDA?
Babyleo TN500 received FDA 510(k) clearance on 2026-02-13, under approval number K251619.
What company makes Babyleo TN500?
Babyleo TN500 is manufactured by Drägerwerk AG & Co. KGaA.
What is the FDA product code for Babyleo TN500?
The FDA product code for Babyleo TN500 is FMZ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.