FDA 510(k)

Fibroid Mapping Reviewer Application (FMRA)

Номер K: K222683 · 2023-07-17

Дата решения2023-07-17

Код продуктаLLZ

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

Fibroid Mapping Reviewer Application (FMRA) is the device name listed in this FDA 510(k) record. The listed applicant is Nesa Medtech Private Limited. It received FDA 510(k) clearance on 2023-07-17 under 510(k) number K222683. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Fibroid Mapping Reviewer Application (FMRA)?

Fibroid Mapping Reviewer Application (FMRA) is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is Nesa Medtech Private Limited. The 510(k) number is K222683.

When did Fibroid Mapping Reviewer Application (FMRA) receive FDA 510(k) clearance?

Fibroid Mapping Reviewer Application (FMRA) received FDA 510(k) clearance on 2023-07-17, under 510(k) number K222683.

Who is the listed applicant for Fibroid Mapping Reviewer Application (FMRA)?

The FDA 510(k) record lists Nesa Medtech Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fibroid Mapping Reviewer Application (FMRA)?

The FDA product code for Fibroid Mapping Reviewer Application (FMRA) is LLZ.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: LLZ)

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio AnalysisReplasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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