Nautilus
K-Number: K220871 · 2022-04-18
ApplicantDornier Medtech America, Inc.
Decision Date2022-04-18
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Nautilus is a medical device manufactured by Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2022-04-18 under approval number K220871. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Nautilus?
Nautilus is a medical device that received FDA 510(k) clearance on 2022-04-18. It is manufactured by Dornier Medtech America, Inc.. The 510(k) number is K220871.
When was Nautilus approved by the FDA?
Nautilus received FDA 510(k) clearance on 2022-04-18, under approval number K220871.
What company makes Nautilus?
Nautilus is manufactured by Dornier Medtech America, Inc..
What is the FDA product code for Nautilus?
The FDA product code for Nautilus is JAA.
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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.