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 the device name listed in this FDA 510(k) record. The listed applicant is Sibel, Inc.. It received FDA 510(k) clearance on 2021-09-14 under 510(k) 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. The listed applicant is Sibel, Inc.. The 510(k) number is K211305.

When did ANNE One receive FDA 510(k) clearance?

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

Who is the listed applicant for ANNE One?

The FDA 510(k) record lists Sibel, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANNE One?

The FDA product code for ANNE One is DRG.

Other records listing Sibel, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.