FDA 510(k)

ANNE One

K-Number: K211305 · 2021-09-14

Decision Date2021-09-14

Product CodeDRG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ANNE One is a medical device manufactured by Sibel, Inc.. It received FDA 510(k) clearance on 2021-09-14 under approval number K211305. 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 2021-09-14. It is manufactured by Sibel, Inc.. The 510(k) number is K211305.

When was ANNE One approved by the FDA?

ANNE One received FDA 510(k) clearance on 2021-09-14, under approval number K211305.

What company makes ANNE One?

ANNE One is manufactured by Sibel, Inc..

What is the FDA product code for ANNE One?

The FDA product code for ANNE One is DRG.

Other Devices by Sibel, Inc.

K221530ANNE Pediatric K220095ANNE Sleep

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.