FDA 510(k)

PM-8000 PATIENT MONITOR, MODEL 8000

K-Number: K032733 · 2004-03-03

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Decision Date2004-03-03

Product CodeDRT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PM-8000 PATIENT MONITOR, MODEL 8000 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 2004-03-03 under 510(k) number K032733. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PM-8000 PATIENT MONITOR, MODEL 8000?

PM-8000 PATIENT MONITOR, MODEL 8000 is a medical device that received FDA 510(k) clearance on 2004-03-03. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K032733.

When did PM-8000 PATIENT MONITOR, MODEL 8000 receive FDA 510(k) clearance?

PM-8000 PATIENT MONITOR, MODEL 8000 received FDA 510(k) clearance on 2004-03-03, under 510(k) number K032733.

Who is the listed applicant for PM-8000 PATIENT MONITOR, MODEL 8000?

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-8000 PATIENT MONITOR, MODEL 8000?

The FDA product code for PM-8000 PATIENT MONITOR, MODEL 8000 is DRT.

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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.