Nautilus
FDA 510(k) K220871 · Dornier Medtech America, Inc.
510(k) numberK220871
Submission
- Device name
- Nautilus
- Applicant
- Dornier Medtech America, Inc.
Kennesaw, GA, US - Received
- March 25, 2022
- Decision date
- April 18, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Nautilus cleared by the FDA?
Nautilus (K220871) received a 510(k) decision of Substantially Equivalent on April 18, 2022, 24 days after the submission was received.
What is the product code of K220871?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.