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FDA 510(k)

CuffTrek

K-Number: K242642 · 2025-03-07

Decision Date2025-03-07
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CuffTrek is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Longmann Tech Co., Ltd.. It received FDA 510(k) clearance on 2025-03-07 under 510(k) 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. The listed applicant is Shanghai Longmann Tech Co., Ltd.. The 510(k) number is K242642.

When did CuffTrek receive FDA 510(k) clearance?

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

Who is the listed applicant for CuffTrek?

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

What is the FDA product code for CuffTrek?

The FDA product code for CuffTrek is BSK.

Related Devices (Code: BSK)

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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