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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2022-04-18 under 510(k) 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. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K220871.

When did Nautilus receive FDA 510(k) clearance?

Nautilus received FDA 510(k) clearance on 2022-04-18, under 510(k) number K220871.

Who is the listed applicant for Nautilus?

The FDA 510(k) record lists Dornier Medtech America, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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