ANNE Limb
K-Number: K240305 · 2024-05-28
ApplicantSibel Health, Inc.
Decision Date2024-05-28
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ANNE Limb is a medical device manufactured by Sibel Health, Inc.. It received FDA 510(k) clearance on 2024-05-28 under approval number K240305. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ANNE Limb?
ANNE Limb is a medical device that received FDA 510(k) clearance on 2024-05-28. It is manufactured by Sibel Health, Inc.. The 510(k) number is K240305.
When was ANNE Limb approved by the FDA?
ANNE Limb received FDA 510(k) clearance on 2024-05-28, under approval number K240305.
What company makes ANNE Limb?
ANNE Limb is manufactured by Sibel Health, Inc..
What is the FDA product code for ANNE Limb?
The FDA product code for ANNE Limb is DQA.
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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.