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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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Hulu Devices Co., Ltd.. It received FDA 510(k) clearance on 2018-03-08 under 510(k) 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. The listed applicant is Shanghai Hulu Devices Co., Ltd.. The 510(k) number is K180335.

When did Accutension Smartphone Auscultatory Blood receive FDA 510(k) clearance?

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

Who is the listed applicant for Accutension Smartphone Auscultatory Blood?

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

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

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

Other records listing Shanghai Hulu Devices Co., Ltd. as applicant

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Related Devices (Code: DXQ)

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.

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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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