FDA 510(k)

MODIFICATION TO PM-8000 PATIENT MONITOR

K-Number: K043348 · 2005-01-06

ApplicantShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Decision Date2005-01-06

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PM-8000 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 2005-01-06 under 510(k) number K043348. 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 MODIFICATION TO PM-8000 PATIENT MONITOR?

MODIFICATION TO PM-8000 PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2005-01-06. The listed applicant is Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. The 510(k) number is K043348.

When did MODIFICATION TO PM-8000 PATIENT MONITOR receive FDA 510(k) clearance?

MODIFICATION TO PM-8000 PATIENT MONITOR received FDA 510(k) clearance on 2005-01-06, under 510(k) number K043348.

Who is the listed applicant for MODIFICATION TO PM-8000 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 MODIFICATION TO PM-8000 PATIENT MONITOR?

The FDA product code for MODIFICATION TO PM-8000 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.