FDA 510(k)

MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR

K-Number: K111652 · 2011-07-13

ApplicantMicrolife Intellectual Property GmbH

Decision Date2011-07-13

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Intellectual Property GmbH. It received FDA 510(k) clearance on 2011-07-13 under 510(k) number K111652. 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 MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR?

MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR is a medical device that received FDA 510(k) clearance on 2011-07-13. The listed applicant is Microlife Intellectual Property GmbH. The 510(k) number is K111652.

When did MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR receive FDA 510(k) clearance?

MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR received FDA 510(k) clearance on 2011-07-13, under 510(k) number K111652.

Who is the listed applicant for MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR?

The FDA 510(k) record lists Microlife Intellectual Property GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR?

The FDA product code for MICROLIFE AUTOMATIC TALKING BLOOD PRESSURE MONITOR is DXN.

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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.