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FDA 510(k)

Digital Automatic Wrist Blood Pressure Monitor MD4300

K-Number: K171379 · 2018-04-10

Decision Date2018-04-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Digital Automatic Wrist Blood Pressure Monitor MD4300 is the device name listed in this FDA 510(k) record. The listed applicant is Grandway Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2018-04-10 under 510(k) number K171379. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Digital Automatic Wrist Blood Pressure Monitor MD4300?

Digital Automatic Wrist Blood Pressure Monitor MD4300 is a medical device that received FDA 510(k) clearance on 2018-04-10. The listed applicant is Grandway Technology (Shenzhen) Limited. The 510(k) number is K171379.

When did Digital Automatic Wrist Blood Pressure Monitor MD4300 receive FDA 510(k) clearance?

Digital Automatic Wrist Blood Pressure Monitor MD4300 received FDA 510(k) clearance on 2018-04-10, under 510(k) number K171379.

Who is the listed applicant for Digital Automatic Wrist Blood Pressure Monitor MD4300?

The FDA 510(k) record lists Grandway Technology (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Automatic Wrist Blood Pressure Monitor MD4300?

The FDA product code for Digital Automatic Wrist Blood Pressure Monitor MD4300 is DXN.

Related Clinical Trials

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.

Other records listing Grandway Technology (Shenzhen) Limited as applicant

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.

Related Devices (Code: DXN)

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.

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.