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FDA 510(k)

H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM

K-Number: K043186 · 2004-12-06

ApplicantHealth & Life Co., Ltd.
Decision Date2004-12-06
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM is the device name listed in this FDA 510(k) record. The listed applicant is Health & Life Co., Ltd.. It received FDA 510(k) clearance on 2004-12-06 under 510(k) number K043186. 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 H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM?

H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM is a medical device that received FDA 510(k) clearance on 2004-12-06. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K043186.

When did H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM receive FDA 510(k) clearance?

H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM received FDA 510(k) clearance on 2004-12-06, under 510(k) number K043186.

Who is the listed applicant for H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM?

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

What is the FDA product code for H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM?

The FDA product code for H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM is DXN.

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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.

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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.

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