FDA 510(k)

Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE

Номер K: K170835 · 2018-06-15

Дата решения2018-06-15

Код продуктаEGJ

Консультативный комитетPM

РешениеSubstantially Equivalent

Описание устройства

Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Hightech Development. It received FDA 510(k) clearance on 2018-06-15 under 510(k) number K170835. The device is classified under product code EGJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE?

Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE is a medical device that received FDA 510(k) clearance on 2018-06-15. The listed applicant is Hightech Development. The 510(k) number is K170835.

When did Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE receive FDA 510(k) clearance?

Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE received FDA 510(k) clearance on 2018-06-15, under 510(k) number K170835.

Who is the listed applicant for Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE?

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

What is the FDA product code for Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE?

The FDA product code for Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE is EGJ.

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: EGJ)

K242041STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd.K241267Hidroxa SE30Hidroxa Medical AB K232020Iontophoresis ElectrodesTop-Rank Health Care Co., Ltd.K192749DermadryDermadry Laboratories, Inc.K191436SaalioSaalmann Medical GmbH & Co. KG K170291IontoDCSoterix Medical, Inc.

Официальный источник

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