Savina 300
K-Number: K180779 · 2019-01-17
ApplicantDragerwerk AG & CO Kgaa
Decision Date2019-01-17
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Savina 300 is a medical device manufactured by Dragerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2019-01-17 under approval number K180779. 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 Savina 300?
Savina 300 is a medical device that received FDA 510(k) clearance on 2019-01-17. It is manufactured by Dragerwerk AG & CO Kgaa. The 510(k) number is K180779.
When was Savina 300 approved by the FDA?
Savina 300 received FDA 510(k) clearance on 2019-01-17, under approval number K180779.
What company makes Savina 300?
Savina 300 is manufactured by Dragerwerk AG & CO Kgaa.
What is the FDA product code for Savina 300?
The FDA product code for Savina 300 is CBK.
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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.