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FDA 510(k)

Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope

K-Number: K211084 · 2021-10-19

ApplicantShanghai Caremate Medical Device Co., Ltd.
Decision Date2021-10-19
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope is a medical device manufactured by Shanghai Caremate Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-10-19 under approval number K211084. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope?

Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope is a medical device that received FDA 510(k) clearance on 2021-10-19. It is manufactured by Shanghai Caremate Medical Device Co., Ltd.. The 510(k) number is K211084.

When was Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope approved by the FDA?

Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope received FDA 510(k) clearance on 2021-10-19, under approval number K211084.

What company makes Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope?

Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope is manufactured by Shanghai Caremate Medical Device Co., Ltd..

What is the FDA product code for Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope?

The FDA product code for Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope is DXQ.

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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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