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FDA 510(k)

KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR

K-Number: K120672 · 2012-06-01

Decision Date2012-06-01
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2012-06-01 under 510(k) number K120672. 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 KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR?

KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 2012-06-01. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K120672.

When did KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR receive FDA 510(k) clearance?

KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR received FDA 510(k) clearance on 2012-06-01, under 510(k) number K120672.

Who is the listed applicant for KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR?

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

What is the FDA product code for KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR?

The FDA product code for KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR 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.

Other records listing Andon Health Co, Ltd. as applicant

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.

View all 83 devices →

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

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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