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FDA 510(k)

SV600, SV800 Ventilator

K-Number: K243767 · 2025-08-28

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Decision Date2025-08-28
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SV600, SV800 Ventilator is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-08-28 under approval number K243767. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SV600, SV800 Ventilator?

SV600, SV800 Ventilator is a medical device that received FDA 510(k) clearance on 2025-08-28. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K243767.

When was SV600, SV800 Ventilator approved by the FDA?

SV600, SV800 Ventilator received FDA 510(k) clearance on 2025-08-28, under approval number K243767.

What company makes SV600, SV800 Ventilator?

SV600, SV800 Ventilator is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

What is the FDA product code for SV600, SV800 Ventilator?

The FDA product code for SV600, SV800 Ventilator is CBK.

Other Devices by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

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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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