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FDA 510(k)

A8, A9 Anesthesia System

K-Number: K201957 · 2021-03-26

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Decision Date2021-03-26
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

A8, A9 Anesthesia System is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-03-26 under approval number K201957. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A8, A9 Anesthesia System?

A8, A9 Anesthesia System is a medical device that received FDA 510(k) clearance on 2021-03-26. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K201957.

When was A8, A9 Anesthesia System approved by the FDA?

A8, A9 Anesthesia System received FDA 510(k) clearance on 2021-03-26, under approval number K201957.

What company makes A8, A9 Anesthesia System?

A8, A9 Anesthesia System is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

What is the FDA product code for A8, A9 Anesthesia System?

The FDA product code for A8, A9 Anesthesia System is BSZ.

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

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Related Devices (Code: BSZ)

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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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