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FDA 510(k)

SysMed S/T

K-Number: K192177 · 2020-11-25

ApplicantSysmed (China) Co., Ltd.
Decision Date2020-11-25
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SysMed S/T is a medical device manufactured by Sysmed (China) Co., Ltd.. It received FDA 510(k) clearance on 2020-11-25 under approval number K192177. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SysMed S/T?

SysMed S/T is a medical device that received FDA 510(k) clearance on 2020-11-25. It is manufactured by Sysmed (China) Co., Ltd.. The 510(k) number is K192177.

When was SysMed S/T approved by the FDA?

SysMed S/T received FDA 510(k) clearance on 2020-11-25, under approval number K192177.

What company makes SysMed S/T?

SysMed S/T is manufactured by Sysmed (China) Co., Ltd..

What is the FDA product code for SysMed S/T?

The FDA product code for SysMed S/T is BZD.

Other Devices by Sysmed (China) Co., Ltd.

K172234Oxygen Concentrator

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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.

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