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FDA 510(k)

CuffTrek

K-Number: K242642 · 2025-03-07

ApplicantShanghai Longmann Tech Co., Ltd.
Decision Date2025-03-07
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CuffTrek is a medical device manufactured by Shanghai Longmann Tech Co., Ltd.. It received FDA 510(k) clearance on 2025-03-07 under approval number K242642. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CuffTrek?

CuffTrek is a medical device that received FDA 510(k) clearance on 2025-03-07. It is manufactured by Shanghai Longmann Tech Co., Ltd.. The 510(k) number is K242642.

When was CuffTrek approved by the FDA?

CuffTrek received FDA 510(k) clearance on 2025-03-07, under approval number K242642.

What company makes CuffTrek?

CuffTrek is manufactured by Shanghai Longmann Tech Co., Ltd..

What is the FDA product code for CuffTrek?

The FDA product code for CuffTrek is BSK.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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