FDA 510(k)

ElintMAX Respiratory Monitor (ElintMAX Monitor A1)

Номер K: K260226 · 2026-09-16

Дата решения2026-09-16

Код продуктаBZK

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

ElintMAX Respiratory Monitor (ElintMAX Monitor A1) is the device name listed in this FDA 510(k) record. The listed applicant is Amptron Medical, Inc.. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K260226. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the ElintMAX Respiratory Monitor (ElintMAX Monitor A1)?

ElintMAX Respiratory Monitor (ElintMAX Monitor A1) is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Amptron Medical, Inc.. The 510(k) number is K260226.

When did ElintMAX Respiratory Monitor (ElintMAX Monitor A1) receive FDA 510(k) clearance?

ElintMAX Respiratory Monitor (ElintMAX Monitor A1) received FDA 510(k) clearance on 2026-09-16, under 510(k) number K260226.

Who is the listed applicant for ElintMAX Respiratory Monitor (ElintMAX Monitor A1)?

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

What is the FDA product code for ElintMAX Respiratory Monitor (ElintMAX Monitor A1)?

The FDA product code for ElintMAX Respiratory Monitor (ElintMAX Monitor A1) is BZK.

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: BZK)

K192584BEACON Caresystem Model 00002144Mermaid Care A/S K192595ExSpiron 2XiRespiratory Motion K180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K173181ExSpiron 1XiRespiratory Motion, Inc.K162131ExSpiron 1XiRespiratory Motion, Inc.

Официальный источник

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