FDA 510(k)

MoistureMeterD Compact, LymphScanner

Номер K: K220557 · 2022-05-27

Дата решения2022-05-27

Код продуктаOBH

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

MoistureMeterD Compact, LymphScanner is the device name listed in this FDA 510(k) record. The listed applicant is Delfin Technologies, Ltd.. It received FDA 510(k) clearance on 2022-05-27 under 510(k) number K220557. The device is classified under product code OBH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the MoistureMeterD Compact, LymphScanner?

MoistureMeterD Compact, LymphScanner is a medical device that received FDA 510(k) clearance on 2022-05-27. The listed applicant is Delfin Technologies, Ltd.. The 510(k) number is K220557.

When did MoistureMeterD Compact, LymphScanner receive FDA 510(k) clearance?

MoistureMeterD Compact, LymphScanner received FDA 510(k) clearance on 2022-05-27, under 510(k) number K220557.

Who is the listed applicant for MoistureMeterD Compact, LymphScanner?

The FDA 510(k) record lists Delfin Technologies, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MoistureMeterD Compact, LymphScanner?

The FDA product code for MoistureMeterD Compact, LymphScanner is OBH.

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: OBH)

K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)ImpediMed Limited K230530SOZO ProImpediMed Limited K180126SOZOImpediMed Limited K172122SOZOImpediMed Limited

Официальный источник

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