Philips MR Patient Care Portal

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

Invivo Corporation

The following data is part of a premarket notification filed by Invivo Corporation with the FDA for Philips Mr Patient Care Portal.

Pre-market Notification Details

Device IDK212227
510k NumberK212227
Device Name:Philips MR Patient Care Portal
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant Invivo Corporation 12151 Research Parkway Orlando,  FL  32826
ContactMaria Keelan
CorrespondentMaria Keelan
Invivo Corporation 12151 Research Parkway Orlando,  FL  32826
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-16
Decision Date2021-09-30

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