DEKA Loop
K-Number: K234055 · 2024-03-13
ApplicantDeka Research and Development
Decision Date2024-03-13
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
DEKA Loop is a medical device manufactured by Deka Research and Development. It received FDA 510(k) clearance on 2024-03-13 under approval number K234055. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DEKA Loop?
DEKA Loop is a medical device that received FDA 510(k) clearance on 2024-03-13. It is manufactured by Deka Research and Development. The 510(k) number is K234055.
When was DEKA Loop approved by the FDA?
DEKA Loop received FDA 510(k) clearance on 2024-03-13, under approval number K234055.
What company makes DEKA Loop?
DEKA Loop is manufactured by Deka Research and Development.
What is the FDA product code for DEKA Loop?
The FDA product code for DEKA Loop is QJI.
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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.