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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Sibel Health, Inc.. It received FDA 510(k) clearance on 2024-05-28 under 510(k) 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. The listed applicant is Sibel Health, Inc.. The 510(k) number is K240305.

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

ANNE Limb received FDA 510(k) clearance on 2024-05-28, under 510(k) number K240305.

Who is the listed applicant for ANNE Limb?

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

What is the FDA product code for ANNE Limb?

The FDA product code for ANNE Limb is DQA.

Other records listing Sibel Health, 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.

K253021ANNE MaternalK242842ANNE View, Central HubK240251ANNE ChestK223711ANNE One

Related Devices (Code: DQA)

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.

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