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FDA 510(k)

Accutension Smartphone Auscultatory Blood

K-Number: K180335 · 2018-03-08

ApplicantShanghai Hulu Devices Co., Ltd.
Decision Date2018-03-08
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Accutension Smartphone Auscultatory Blood is a medical device manufactured by Shanghai Hulu Devices Co., Ltd.. It received FDA 510(k) clearance on 2018-03-08 under approval number K180335. 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 Accutension Smartphone Auscultatory Blood?

Accutension Smartphone Auscultatory Blood is a medical device that received FDA 510(k) clearance on 2018-03-08. It is manufactured by Shanghai Hulu Devices Co., Ltd.. The 510(k) number is K180335.

When was Accutension Smartphone Auscultatory Blood approved by the FDA?

Accutension Smartphone Auscultatory Blood received FDA 510(k) clearance on 2018-03-08, under approval number K180335.

What company makes Accutension Smartphone Auscultatory Blood?

Accutension Smartphone Auscultatory Blood is manufactured by Shanghai Hulu Devices Co., Ltd..

What is the FDA product code for Accutension Smartphone Auscultatory Blood?

The FDA product code for Accutension Smartphone Auscultatory Blood is DXQ.

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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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