Babyroo TN300
K-Number: K243606 · 2025-01-17
ApplicantDraeger Medical Systems, Inc.
Decision Date2025-01-17
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Babyroo TN300 is a medical device manufactured by Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2025-01-17 under approval number K243606. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Babyroo TN300?
Babyroo TN300 is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Draeger Medical Systems, Inc.. The 510(k) number is K243606.
When was Babyroo TN300 approved by the FDA?
Babyroo TN300 received FDA 510(k) clearance on 2025-01-17, under approval number K243606.
What company makes Babyroo TN300?
Babyroo TN300 is manufactured by Draeger Medical Systems, Inc..
What is the FDA product code for Babyroo TN300?
The FDA product code for Babyroo TN300 is FMT.
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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.