FDA 510(k)

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

Número K: K163464 · 2017-09-05

Data da decisão2017-09-05

Código do produtoBZD

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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