FDA 510(k)

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4

Номер K: K191435 · 2019-09-06

Дата решения2019-09-06

Код продуктаGZF

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 is the device name listed in this FDA 510(k) record. The listed applicant is Nalu Medical, Inc.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K191435. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4?

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Nalu Medical, Inc.. The 510(k) number is K191435.

When did IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 receive FDA 510(k) clearance?

IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 received FDA 510(k) clearance on 2019-09-06, under 510(k) number K191435.

Who is the listed applicant for IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4?

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

What is the FDA product code for IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4?

The FDA product code for IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 is GZF.

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: GZF)

K253877StimTrial Neuromodulation SystemBioventus, LLC K243782StimTrial Neuromodulation SystemBioventus, LLC K243678TalisMann Neuromodulation SystemBioventus, LLC K232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific Neuromodulation K233162Freedom Peripheral Nerve Stimulator (PNS) SystemCuronix K221303Neuspera Nuity SystemNeuspera Medical, Inc.

Официальный источник

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