9Line
K-Number: K211941 · 2022-01-27
ApplicantEnergetic Designs, Inc.
Decision Date2022-01-27
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
9Line is a medical device manufactured by Energetic Designs, Inc.. It received FDA 510(k) clearance on 2022-01-27 under approval number K211941. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the 9Line?
9Line is a medical device that received FDA 510(k) clearance on 2022-01-27. It is manufactured by Energetic Designs, Inc.. The 510(k) number is K211941.
When was 9Line approved by the FDA?
9Line received FDA 510(k) clearance on 2022-01-27, under approval number K211941.
What company makes 9Line?
9Line is manufactured by Energetic Designs, Inc..
What is the FDA product code for 9Line?
The FDA product code for 9Line is DSA.
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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.