FDA 510(k)

SysMed S/T

K-Number: K192177 · 2020-11-25

Decision Date2020-11-25

Product CodeBZD

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SysMed S/T is the device name listed in this FDA 510(k) record. The listed applicant is Sysmed (China) Co., Ltd.. It received FDA 510(k) clearance on 2020-11-25 under 510(k) 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. The listed applicant is Sysmed (China) Co., Ltd.. The 510(k) number is K192177.

When did SysMed S/T receive FDA 510(k) clearance?

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

Who is the listed applicant for SysMed S/T?

The FDA 510(k) record lists Sysmed (China) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Sysmed (China) 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.

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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.