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FDA 510(k)

Mindray SV600 Ventilator, Mindray SV800 Ventilator

K-Number: K220107 · 2023-06-16

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Decision Date2023-06-16
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Mindray SV600 Ventilator, Mindray SV800 Ventilator is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2023-06-16 under approval number K220107. 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 Mindray SV600 Ventilator, Mindray SV800 Ventilator?

Mindray SV600 Ventilator, Mindray SV800 Ventilator is a medical device that received FDA 510(k) clearance on 2023-06-16. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K220107.

When was Mindray SV600 Ventilator, Mindray SV800 Ventilator approved by the FDA?

Mindray SV600 Ventilator, Mindray SV800 Ventilator received FDA 510(k) clearance on 2023-06-16, under approval number K220107.

What company makes Mindray SV600 Ventilator, Mindray SV800 Ventilator?

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

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

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

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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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