FDA 510(k)

core nova Complete Operating Room Endoscopy

Номер K: K151282 · 2016-01-12

ЗаявительRichard Wolf Medical Instruments Corp.

Дата решения2016-01-12

Код продуктаODA

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

core nova Complete Operating Room Endoscopy is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 2016-01-12 under 510(k) number K151282. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the core nova Complete Operating Room Endoscopy?

core nova Complete Operating Room Endoscopy is a medical device that received FDA 510(k) clearance on 2016-01-12. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K151282.

When did core nova Complete Operating Room Endoscopy receive FDA 510(k) clearance?

core nova Complete Operating Room Endoscopy received FDA 510(k) clearance on 2016-01-12, under 510(k) number K151282.

Who is the listed applicant for core nova Complete Operating Room Endoscopy?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for core nova Complete Operating Room Endoscopy?

The FDA product code for core nova Complete Operating Room Endoscopy is ODA.

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: ODA)

K232406KARL STORZ OR1™ SCB CONTROL (WU300)Karl Storz SE & CO. KG K221929Smith+Nephew INTELLIO TabletSmith+Nephew K203566Tablet ApplicationSmith & Nephew K192876INTELLIO Tablet ApplicationSmith & Nephew K153205IDSS ForceTriad Control ModuleBlack Diamond Video, Inc.

Официальный источник

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