FDA 510(k)

PM-9000 EXPRESS PATIENT MONITOR

K-Number: K053234 · 2006-05-04

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Decision Date2006-05-04

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PM-9000 EXPRESS PATIENT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2006-05-04 under 510(k) number K053234. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PM-9000 EXPRESS PATIENT MONITOR?

PM-9000 EXPRESS PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2006-05-04. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K053234.

When did PM-9000 EXPRESS PATIENT MONITOR receive FDA 510(k) clearance?

PM-9000 EXPRESS PATIENT MONITOR received FDA 510(k) clearance on 2006-05-04, under 510(k) number K053234.

Who is the listed applicant for PM-9000 EXPRESS PATIENT MONITOR?

The FDA 510(k) record lists Shenzhen Mindray Bio-Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PM-9000 EXPRESS PATIENT MONITOR?

The FDA product code for PM-9000 EXPRESS PATIENT MONITOR is MWI.

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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.