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FDA 510(k)

ANNE Chest

K-Number: K240251 · 2024-06-03

ApplicantSibel Health, Inc.
Decision Date2024-06-03
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANNE Chest 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 2024-06-03 under 510(k) number K240251. 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 Chest?

ANNE Chest is a medical device that received FDA 510(k) clearance on 2024-06-03. The listed applicant is Sibel Health, Inc.. The 510(k) number is K240251.

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

ANNE Chest received FDA 510(k) clearance on 2024-06-03, under 510(k) number K240251.

Who is the listed applicant for ANNE Chest?

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 Chest?

The FDA product code for ANNE Chest is DRG.

Related Clinical Trials

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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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 HubK240305ANNE LimbK223711ANNE One

Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

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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