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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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Caremate Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-10-19 under 510(k) 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. The listed applicant is Shanghai Caremate Medical Device Co., Ltd.. The 510(k) number is K211084.

When did Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope receive FDA 510(k) clearance?

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

Who is the listed applicant for Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope?

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

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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