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FDA 510(k)

GMC Upper Arm Automatic Blood Pressure Monitor

K-Number: K181931 · 2019-04-04

ApplicantGmc, Inc.
Decision Date2019-04-04
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GMC Upper Arm Automatic Blood Pressure Monitor is a medical device manufactured by Gmc, Inc.. It received FDA 510(k) clearance on 2019-04-04 under approval number K181931. 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 GMC Upper Arm Automatic Blood Pressure Monitor?

GMC Upper Arm Automatic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2019-04-04. It is manufactured by Gmc, Inc.. The 510(k) number is K181931.

When was GMC Upper Arm Automatic Blood Pressure Monitor approved by the FDA?

GMC Upper Arm Automatic Blood Pressure Monitor received FDA 510(k) clearance on 2019-04-04, under approval number K181931.

What company makes GMC Upper Arm Automatic Blood Pressure Monitor?

GMC Upper Arm Automatic Blood Pressure Monitor is manufactured by Gmc, Inc..

What is the FDA product code for GMC Upper Arm Automatic Blood Pressure Monitor?

The FDA product code for GMC Upper Arm Automatic 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.