FDA 510(k)

ClearUP Sinus Pain Relief

Номер K: K182025 · 2019-01-02

Дата решения2019-01-02

Код продуктаGZJ

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

ClearUP Sinus Pain Relief is the device name listed in this FDA 510(k) record. The listed applicant is Tivic Health Systems, Inc.. It received FDA 510(k) clearance on 2019-01-02 under 510(k) number K182025. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the ClearUP Sinus Pain Relief?

ClearUP Sinus Pain Relief is a medical device that received FDA 510(k) clearance on 2019-01-02. The listed applicant is Tivic Health Systems, Inc.. The 510(k) number is K182025.

When did ClearUP Sinus Pain Relief receive FDA 510(k) clearance?

ClearUP Sinus Pain Relief received FDA 510(k) clearance on 2019-01-02, under 510(k) number K182025.

Who is the listed applicant for ClearUP Sinus Pain Relief?

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

What is the FDA product code for ClearUP Sinus Pain Relief?

The FDA product code for ClearUP Sinus Pain Relief is GZJ.

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: GZJ)

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

Официальный источник

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