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FDA 510(k)

ANNE View, Central Hub

K-Number: K242842 · 2025-01-08

ApplicantSibel Health, Inc.
Decision Date2025-01-08
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANNE View, Central Hub 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 2025-01-08 under 510(k) number K242842. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANNE View, Central Hub?

ANNE View, Central Hub is a medical device that received FDA 510(k) clearance on 2025-01-08. The listed applicant is Sibel Health, Inc.. The 510(k) number is K242842.

When did ANNE View, Central Hub receive FDA 510(k) clearance?

ANNE View, Central Hub received FDA 510(k) clearance on 2025-01-08, under 510(k) number K242842.

Who is the listed applicant for ANNE View, Central Hub?

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 View, Central Hub?

The FDA product code for ANNE View, Central Hub is MSX.

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.

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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.

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