ANNE Chest
K-Number: K240251 · 2024-06-03
ApplicantSibel Health, Inc.
Decision Date2024-06-03
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ANNE Chest is a medical device manufactured by Sibel Health, Inc.. It received FDA 510(k) clearance on 2024-06-03 under approval number K240251. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ANNE Chest?
ANNE Chest is a medical device that received FDA 510(k) clearance on 2024-06-03. It is manufactured by Sibel Health, Inc.. The 510(k) number is K240251.
When was ANNE Chest approved by the FDA?
ANNE Chest received FDA 510(k) clearance on 2024-06-03, under approval number K240251.
What company makes ANNE Chest?
ANNE Chest is manufactured by Sibel Health, Inc..
What is the FDA product code for ANNE Chest?
The FDA product code for ANNE Chest is DRG.
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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.