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FDA 510(k)

Mindray SV600 Ventilator, Mindray SV800 Ventilator

K-Number: K220107 · 2023-06-16

Decision Date2023-06-16
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Mindray SV600 Ventilator, Mindray SV800 Ventilator 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 2023-06-16 under 510(k) 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. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K220107.

When did Mindray SV600 Ventilator, Mindray SV800 Ventilator receive FDA 510(k) clearance?

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

Who is the listed applicant for Mindray SV600 Ventilator, Mindray SV800 Ventilator?

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 Mindray SV600 Ventilator, Mindray SV800 Ventilator?

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

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 88 devices →

Related Devices (Code: CBK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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