ANNE One
K-Number: K223711 · 2023-08-10
ApplicantSibel Health, Inc.
Decision Date2023-08-10
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ANNE One is a medical device manufactured by Sibel Health, Inc.. It received FDA 510(k) clearance on 2023-08-10 under approval number K223711. 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 One?
ANNE One is a medical device that received FDA 510(k) clearance on 2023-08-10. It is manufactured by Sibel Health, Inc.. The 510(k) number is K223711.
When was ANNE One approved by the FDA?
ANNE One received FDA 510(k) clearance on 2023-08-10, under approval number K223711.
What company makes ANNE One?
ANNE One is manufactured by Sibel Health, Inc..
What is the FDA product code for ANNE One?
The FDA product code for ANNE One 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.