FDA 510(k)

SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8

K-Number: K103652 · 2011-01-13

Decision Date2011-01-13

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systesms. It received FDA 510(k) clearance on 2011-01-13 under 510(k) number K103652. 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 SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8?

SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8 is a medical device that received FDA 510(k) clearance on 2011-01-13. The listed applicant is Philips Medical Systesms. The 510(k) number is K103652.

When did SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8 receive FDA 510(k) clearance?

SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8 received FDA 510(k) clearance on 2011-01-13, under 510(k) number K103652.

Who is the listed applicant for SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8?

The FDA 510(k) record lists Philips Medical Systesms as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8?

The FDA product code for SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8 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.