FDA 510(k)

C Scope Visualization System

Номер K: K203526 · 2021-01-12

ЗаявительCit Ortho

Дата решения2021-01-12

Код продуктаHRX

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

C Scope Visualization System is the device name listed in this FDA 510(k) record. The listed applicant is Cit Ortho. It received FDA 510(k) clearance on 2021-01-12 under 510(k) number K203526. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the C Scope Visualization System?

C Scope Visualization System is a medical device that received FDA 510(k) clearance on 2021-01-12. The listed applicant is Cit Ortho. The 510(k) number is K203526.

When did C Scope Visualization System receive FDA 510(k) clearance?

C Scope Visualization System received FDA 510(k) clearance on 2021-01-12, under 510(k) number K203526.

Who is the listed applicant for C Scope Visualization System?

The FDA 510(k) record lists Cit Ortho as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C Scope Visualization System?

The FDA product code for C Scope Visualization System is HRX.

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: HRX)

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC K253523Freedom DS™ Decompression SystemSpinal Simplicity K252546VantageTM Lumbar Decompression KitAllevion Medical, LLC K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

Официальный источник

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