FDA 510(k)

Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)

Номер K: K163464 · 2017-09-05

Дата решения2017-09-05

Код продуктаBZD

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) is the device name listed in this FDA 510(k) record. The listed applicant is Bmc Medical., Ltd.. It received FDA 510(k) clearance on 2017-09-05 under 510(k) number K163464. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)?

Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) is a medical device that received FDA 510(k) clearance on 2017-09-05. The listed applicant is Bmc Medical., Ltd.. The 510(k) number is K163464.

When did Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) receive FDA 510(k) clearance?

Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) received FDA 510(k) clearance on 2017-09-05, under 510(k) number K163464.

Who is the listed applicant for Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)?

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

What is the FDA product code for Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)?

The FDA product code for Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) is BZD.

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: BZD)

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed Corp K254104ResScan EssentialsResmed Corp K251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.

Официальный источник

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