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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 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.

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. 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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Other records listing Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as applicant

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Related Devices (Code: 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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