INT Contour
K-Number: K212274 · 2022-04-08
ApplicantCarina Medical, LLC
Decision Date2022-04-08
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
INT Contour is a medical device manufactured by Carina Medical, LLC. It received FDA 510(k) clearance on 2022-04-08 under approval number K212274. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the INT Contour?
INT Contour is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by Carina Medical, LLC. The 510(k) number is K212274.
When was INT Contour approved by the FDA?
INT Contour received FDA 510(k) clearance on 2022-04-08, under approval number K212274.
What company makes INT Contour?
INT Contour is manufactured by Carina Medical, LLC.
What is the FDA product code for INT Contour?
The FDA product code for INT Contour is MUJ.
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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.