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FDA 510(k)

N Series Patient Monitors

K-Number: K213799 · 2022-07-12

Decision Date2022-07-12
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

N Series Patient Monitors is a medical device manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2022-07-12 under approval number K213799. 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 N Series Patient Monitors?

N Series Patient Monitors is a medical device that received FDA 510(k) clearance on 2022-07-12. It is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K213799.

When was N Series Patient Monitors approved by the FDA?

N Series Patient Monitors received FDA 510(k) clearance on 2022-07-12, under approval number K213799.

What company makes N Series Patient Monitors?

N Series Patient Monitors is manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd..

What is the FDA product code for N Series Patient Monitors?

The FDA product code for N Series Patient Monitors is MHX.

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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.