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FDA 510(k)

POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR

K-Number: K031124 · 2003-12-04

ApplicantDatex-Ohmeda, Inc.
Decision Date2003-12-04
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Datex-Ohmeda, Inc.. It received FDA 510(k) clearance on 2003-12-04 under 510(k) number K031124. 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 POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR?

POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR is a medical device that received FDA 510(k) clearance on 2003-12-04. The listed applicant is Datex-Ohmeda, Inc.. The 510(k) number is K031124.

When did POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR receive FDA 510(k) clearance?

POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR received FDA 510(k) clearance on 2003-12-04, under 510(k) number K031124.

Who is the listed applicant for POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR?

The FDA 510(k) record lists Datex-Ohmeda, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR?

The FDA product code for POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR 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.

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