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FDA 510(k)

SV70 Ventilator (SV70)

K-Number: K252182 · 2026-04-06

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Decision Date2026-04-06
Product CodeMNT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the SV70 Ventilator (SV70)?

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

When was SV70 Ventilator (SV70) approved by the FDA?

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

What company makes SV70 Ventilator (SV70)?

SV70 Ventilator (SV70) is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

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

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

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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