FDA 510(k)

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB

K-Number: K190134 · 2019-05-20

Decision Date2019-05-20

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB is a medical device manufactured by Health & Life Co., Ltd.. It received FDA 510(k) clearance on 2019-05-20 under approval number K190134. 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 Full Automatic (NIBP) Blood Pressure Monitor-HL158TB?

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB is a medical device that received FDA 510(k) clearance on 2019-05-20. It is manufactured by Health & Life Co., Ltd.. The 510(k) number is K190134.

When was Full Automatic (NIBP) Blood Pressure Monitor-HL158TB approved by the FDA?

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB received FDA 510(k) clearance on 2019-05-20, under approval number K190134.

What company makes Full Automatic (NIBP) Blood Pressure Monitor-HL158TB?

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB is manufactured by Health & Life Co., Ltd..

What is the FDA product code for Full Automatic (NIBP) Blood Pressure Monitor-HL158TB?

The FDA product code for Full Automatic (NIBP) Blood Pressure Monitor-HL158TB is DXN.

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Other Devices by Health & Life Co., Ltd.

K162338Full Automatic (NIBP) Blood Pressure Monitor K160557Full Automatic (NIBP) Blood Pressure Monitor K161156Full Automatic (NIBP) Blood Pressure Monitor K160336Full Automatic (NIBP) Blood Pressure Monitor K160145Full Automatic (NIBP) Blood Pressure Monitor K153214Full Automatic (NIBP) Blood Pressure Monitor

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Related Devices (Code: DXN)

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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.