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FDA 510(k)

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534

K-Number: K102356 · 2010-09-20

ApplicantAndon Health Co, Ltd.
Decision Date2010-09-20
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 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 2010-09-20 under 510(k) number K102356. 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 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534?

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 is a medical device that received FDA 510(k) clearance on 2010-09-20. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K102356.

When did FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 receive FDA 510(k) clearance?

FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 received FDA 510(k) clearance on 2010-09-20, under 510(k) number K102356.

Who is the listed applicant for FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534?

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 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534?

The FDA product code for FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL MD-534 is 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.

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