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FDA 510(k)

FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01

K-Number: K041400 · 2004-08-24

ApplicantFortifier International Co., Ltd.
Decision Date2004-08-24
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01 is the device name listed in this FDA 510(k) record. The listed applicant is Fortifier International Co., Ltd.. It received FDA 510(k) clearance on 2004-08-24 under 510(k) number K041400. 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 FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01?

FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01 is a medical device that received FDA 510(k) clearance on 2004-08-24. The listed applicant is Fortifier International Co., Ltd.. The 510(k) number is K041400.

When did FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01 receive FDA 510(k) clearance?

FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01 received FDA 510(k) clearance on 2004-08-24, under 510(k) number K041400.

Who is the listed applicant for FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01?

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

What is the FDA product code for FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01?

The FDA product code for FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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