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FDA 510(k)

Babyleo TN500

K-Number: K182859 · 2019-02-22

ApplicantDragerwerk AG & CO Kgaa
Decision Date2019-02-22
Product CodeFMZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Babyleo TN500 is a medical device manufactured by Dragerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2019-02-22 under approval number K182859. 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 2019-02-22. It is manufactured by Dragerwerk AG & CO Kgaa. The 510(k) number is K182859.

When was Babyleo TN500 approved by the FDA?

Babyleo TN500 received FDA 510(k) clearance on 2019-02-22, under approval number K182859.

What company makes Babyleo TN500?

Babyleo TN500 is manufactured by Dragerwerk AG & CO Kgaa.

What is the FDA product code for Babyleo TN500?

The FDA product code for Babyleo TN500 is FMZ.

Other Devices by Dragerwerk AG & CO Kgaa

K180779Savina 300

Related Devices (Code: 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.

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