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FDA 510(k)

BLOOD PRESSURE MONITOR, MODEL M100

K-Number: K032308 · 2003-11-10

Decision Date2003-11-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLOOD PRESSURE MONITOR, MODEL M100 is the device name listed in this FDA 510(k) record. The listed applicant is Meditek Technology, Inc.. It received FDA 510(k) clearance on 2003-11-10 under 510(k) number K032308. 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 BLOOD PRESSURE MONITOR, MODEL M100?

BLOOD PRESSURE MONITOR, MODEL M100 is a medical device that received FDA 510(k) clearance on 2003-11-10. The listed applicant is Meditek Technology, Inc.. The 510(k) number is K032308.

When did BLOOD PRESSURE MONITOR, MODEL M100 receive FDA 510(k) clearance?

BLOOD PRESSURE MONITOR, MODEL M100 received FDA 510(k) clearance on 2003-11-10, under 510(k) number K032308.

Who is the listed applicant for BLOOD PRESSURE MONITOR, MODEL M100?

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

What is the FDA product code for BLOOD PRESSURE MONITOR, MODEL M100?

The FDA product code for BLOOD PRESSURE MONITOR, MODEL M100 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.

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.

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