FDA 510(k)

HyperView Hyperspectral Tissue Oxygenation Measurement System

Номер K: K161237 · 2016-12-16

Дата решения2016-12-16

Код продуктаMUD

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

HyperView Hyperspectral Tissue Oxygenation Measurement System is the device name listed in this FDA 510(k) record. The listed applicant is Hypermed Imaging, Inc.. It received FDA 510(k) clearance on 2016-12-16 under 510(k) number K161237. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the HyperView Hyperspectral Tissue Oxygenation Measurement System?

HyperView Hyperspectral Tissue Oxygenation Measurement System is a medical device that received FDA 510(k) clearance on 2016-12-16. The listed applicant is Hypermed Imaging, Inc.. The 510(k) number is K161237.

When did HyperView Hyperspectral Tissue Oxygenation Measurement System receive FDA 510(k) clearance?

HyperView Hyperspectral Tissue Oxygenation Measurement System received FDA 510(k) clearance on 2016-12-16, under 510(k) number K161237.

Who is the listed applicant for HyperView Hyperspectral Tissue Oxygenation Measurement System?

The FDA 510(k) record lists Hypermed Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HyperView Hyperspectral Tissue Oxygenation Measurement System?

The FDA product code for HyperView Hyperspectral Tissue Oxygenation Measurement System is MUD.

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: MUD)

K254129Spectrum-2Neko Health AB K243324Masimo O3 Regional OximeterMasimo Corporation K250519Lap.Ox™ Laparoscopic Tissue OximeterViOptix, Inc.K240596Индекс автоматической регуляции мозга (CAI) АлгоритмEdwards Lifesciences K241393ODI-TechOdi Medical AS K240601SnapshotNIR model KD205Kent Imaging, Inc.

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