ePM Series Patient monitors
K-Number: K191769 · 2019-10-31
Decision Date2019-10-31
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 2019-10-31 under approval number K191769. 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 2019-10-31. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K191769.
When was ePM Series Patient monitors approved by the FDA?
ePM Series Patient monitors received FDA 510(k) clearance on 2019-10-31, under approval number K191769.
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.