ShapeIT (SI014135)
K-Number: K241611 · 2024-09-03
ApplicantImds Operations B.V.
Decision Date2024-09-03
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ShapeIT (SI014135) is a medical device manufactured by Imds Operations B.V.. It received FDA 510(k) clearance on 2024-09-03 under approval number K241611. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ShapeIT (SI014135)?
ShapeIT (SI014135) is a medical device that received FDA 510(k) clearance on 2024-09-03. It is manufactured by Imds Operations B.V.. The 510(k) number is K241611.
When was ShapeIT (SI014135) approved by the FDA?
ShapeIT (SI014135) received FDA 510(k) clearance on 2024-09-03, under approval number K241611.
What company makes ShapeIT (SI014135)?
ShapeIT (SI014135) is manufactured by Imds Operations B.V..
What is the FDA product code for ShapeIT (SI014135)?
The FDA product code for ShapeIT (SI014135) is DQY.
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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.