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FDA 510(k)

Radio Frequency System

K-Number: K231749 · 2023-10-19

ApplicantShenzhenshi Sincoheren S&T Development Co., Ltd.
Decision Date2023-10-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Radio Frequency System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhenshi Sincoheren S&T Development Co., Ltd.. It received FDA 510(k) clearance on 2023-10-19 under 510(k) number K231749. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Radio Frequency System?

Radio Frequency System is a medical device that received FDA 510(k) clearance on 2023-10-19. The listed applicant is Shenzhenshi Sincoheren S&T Development Co., Ltd.. The 510(k) number is K231749.

When did Radio Frequency System receive FDA 510(k) clearance?

Radio Frequency System received FDA 510(k) clearance on 2023-10-19, under 510(k) number K231749.

Who is the listed applicant for Radio Frequency System?

The FDA 510(k) record lists Shenzhenshi Sincoheren S&T Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radio Frequency System?

The FDA product code for Radio Frequency System is GEI.

Other records listing Shenzhenshi Sincoheren S&T Development 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.

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