Babyleo TN500
K-Number: K162821 · 2017-06-23
ApplicantDraegerwerk AG & CO Kgaa
Decision Date2017-06-23
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Babyleo TN500 is a medical device manufactured by Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2017-06-23 under approval number K162821. 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 2017-06-23. It is manufactured by Draegerwerk AG & CO Kgaa. The 510(k) number is K162821.
When was Babyleo TN500 approved by the FDA?
Babyleo TN500 received FDA 510(k) clearance on 2017-06-23, under approval number K162821.
What company makes Babyleo TN500?
Babyleo TN500 is manufactured by Draegerwerk AG & CO Kgaa.
What is the FDA product code for Babyleo TN500?
The FDA product code for Babyleo TN500 is FMZ.
Other Devices by Draegerwerk AG & CO Kgaa
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K222024Evita V800, Evita V600
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K221118CO2 Mainstream Sensor
K242769VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)
K253647Evita (V800); Evita (V600)
Related Devices (Code: FMZ)
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K190494Infant IncubatorNingbo David Medical Device Co., Ltd.
K182859Babyleo TN500Dragerwerk AG & CO Kgaa
K213553Giraffe Incubator Carestation CS1Datex Ohmeda, Inc.
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.