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FDA 510(k)

ePM Series Patient monitors

K-Number: K200015 · 2020-06-08

Decision Date2020-06-08
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ePM Series Patient monitors is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-06-08 under approval number K200015. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ePM Series Patient monitors?

ePM Series Patient monitors is a medical device that received FDA 510(k) clearance on 2020-06-08. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K200015.

When was ePM Series Patient monitors approved by the FDA?

ePM Series Patient monitors received FDA 510(k) clearance on 2020-06-08, under approval number K200015.

What company makes ePM Series Patient monitors?

ePM Series Patient monitors is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

What is the FDA product code for ePM Series Patient monitors?

The FDA product code for ePM Series Patient monitors is MHX.

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Official Source

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