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FDA 510(k)

Babylog VN800, Babylog VN600

K-Number: K222207 · 2023-05-16

Decision Date2023-05-16
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Babylog VN800, Babylog VN600 is a medical device manufactured by Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2023-05-16 under approval number K222207. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Babylog VN800, Babylog VN600?

Babylog VN800, Babylog VN600 is a medical device that received FDA 510(k) clearance on 2023-05-16. It is manufactured by Draegerwerk AG & CO Kgaa. The 510(k) number is K222207.

When was Babylog VN800, Babylog VN600 approved by the FDA?

Babylog VN800, Babylog VN600 received FDA 510(k) clearance on 2023-05-16, under approval number K222207.

What company makes Babylog VN800, Babylog VN600?

Babylog VN800, Babylog VN600 is manufactured by Draegerwerk AG & CO Kgaa.

What is the FDA product code for Babylog VN800, Babylog VN600?

The FDA product code for Babylog VN800, Babylog VN600 is CBK.

Other Devices by Draegerwerk AG & CO Kgaa

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.