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FDA 510(k)

HX-461

K-Number: K120545 · 2012-10-23

ApplicantSeers Technology Co., Ltd.
Decision Date2012-10-23
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HX-461 is the device name listed in this FDA 510(k) record. The listed applicant is Seers Technology Co., Ltd.. It received FDA 510(k) clearance on 2012-10-23 under 510(k) number K120545. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HX-461?

HX-461 is a medical device that received FDA 510(k) clearance on 2012-10-23. The listed applicant is Seers Technology Co., Ltd.. The 510(k) number is K120545.

When did HX-461 receive FDA 510(k) clearance?

HX-461 received FDA 510(k) clearance on 2012-10-23, under 510(k) number K120545.

Who is the listed applicant for HX-461?

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

What is the FDA product code for HX-461?

The FDA product code for HX-461 is DXN.

Other records listing Seers Technology 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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