FDA 510(k)

SV70 Ventilator (SV70)

Número K: K252182 · 2026-04-06

RequerenteShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Data da decisão2026-04-06

Código do produtoMNT

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

SV70 Ventilator (SV70) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2026-04-06 under 510(k) number K252182. The device is classified under product code MNT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SV70 Ventilator (SV70)?

SV70 Ventilator (SV70) is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K252182.

When did SV70 Ventilator (SV70) receive FDA 510(k) clearance?

SV70 Ventilator (SV70) received FDA 510(k) clearance on 2026-04-06, under 510(k) number K252182.

Who is the listed applicant for SV70 Ventilator (SV70)?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SV70 Ventilator (SV70)?

The FDA product code for SV70 Ventilator (SV70) is MNT.

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Fonte oficial

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