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FDA 510(k)

Electronic Blood Pressure Monitor, model: HTD6602US

K-Number: K223170 · 2023-12-05

Decision Date2023-12-05
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Electronic Blood Pressure Monitor, model: HTD6602US is the device name listed in this FDA 510(k) record. The listed applicant is Hetaida Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-05 under 510(k) number K223170. 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 Electronic Blood Pressure Monitor, model: HTD6602US?

Electronic Blood Pressure Monitor, model: HTD6602US is a medical device that received FDA 510(k) clearance on 2023-12-05. The listed applicant is Hetaida Technology Co., Ltd.. The 510(k) number is K223170.

When did Electronic Blood Pressure Monitor, model: HTD6602US receive FDA 510(k) clearance?

Electronic Blood Pressure Monitor, model: HTD6602US received FDA 510(k) clearance on 2023-12-05, under 510(k) number K223170.

Who is the listed applicant for Electronic Blood Pressure Monitor, model: HTD6602US?

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

What is the FDA product code for Electronic Blood Pressure Monitor, model: HTD6602US?

The FDA product code for Electronic Blood Pressure Monitor, model: HTD6602US 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 Hetaida Technology Co., Ltd. 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.

View all 8 devices →

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.