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FDA 510(k)

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)

K-Number: K253384 · 2026-06-25

Decision Date2026-06-25
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) 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 2026-06-25 under 510(k) number K253384. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)?

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Seers Technology Co., Ltd.. The 510(k) number is K253384.

When did mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) receive FDA 510(k) clearance?

mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) received FDA 510(k) clearance on 2026-06-25, under 510(k) number K253384.

Who is the listed applicant for mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)?

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 mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)?

The FDA product code for mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7) is MWJ.

Related Devices (Code: MWJ)

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.

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.