Full Automatic (NIBP) Blood Pressure Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162338

Identifiers

510(k) Number: K162338 FDA 510(k)
FDA Product Code: DXN FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 870.1130 FDA 510(k)
Regulation Number: 870.1130 FDA 510(k)
Advisory Committee: Cardiovascular FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Our platform provides a comprehensive solution for businesses to manage their operations effectively, with a strong focus on data analysis and AI-powered insights. We strive to provide the highest level of customer satisfaction through our user-friendly interface and dedicated support team.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K162338	Class II	Active

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Manufacturer

Manufacturer: Health & Life Co., Ltd.

Sources (1)

FDA 510(k) K162338 24 fields · synced Oct 7, 2026