FDA 510(k)

Caremed patient cable and leadwires

K-Number: K153188 · 2016-10-24

ApplicantShenzhen Caremed Medical Technology Co., Ltd.

Decision Date2016-10-24

Product CodeDSA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Caremed patient cable and leadwires is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Caremed Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-10-24 under 510(k) number K153188. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Caremed patient cable and leadwires?

Caremed patient cable and leadwires is a medical device that received FDA 510(k) clearance on 2016-10-24. The listed applicant is Shenzhen Caremed Medical Technology Co., Ltd.. The 510(k) number is K153188.

When did Caremed patient cable and leadwires receive FDA 510(k) clearance?

Caremed patient cable and leadwires received FDA 510(k) clearance on 2016-10-24, under 510(k) number K153188.

Who is the listed applicant for Caremed patient cable and leadwires?

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

What is the FDA product code for Caremed patient cable and leadwires?

The FDA product code for Caremed patient cable and leadwires is DSA.

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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.