FDA 510(k)

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)

K-Nummer: K242821 · 2025-02-20

Entscheidungsdatum2025-02-20

ProduktcodeQAS

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) is the device name listed in this FDA 510(k) record. The listed applicant is Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2025-02-20 under 510(k) number K242821. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)?

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) is a medical device that received FDA 510(k) clearance on 2025-02-20. The listed applicant is Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K242821.

When did EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) receive FDA 510(k) clearance?

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) received FDA 510(k) clearance on 2025-02-20, under 510(k) number K242821.

Who is the listed applicant for EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)?

The FDA 510(k) record lists Ever Fortune.Ai, Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)?

The FDA product code for EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) is QAS.

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Weitere Einträge mit Ever Fortune.Ai, Co., Ltd. als Antragsteller

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Alle 15 Geräte anzeigen →

Verwandte Geräte (Code: QAS)

K260906a2z-Abdo-TriageA2z Radiology Ai, Inc.K261085Rapid Vessel Occlusion (Rapid VO)iSchemaview K260729Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI Health K261317BriefCase-TriageAidoc Medical , Ltd.K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.K252421JLK-NCCTJLK, Inc.

Offizielle Quelle

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