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510(k) K152330

Expression MR400 MRI Patient Monitoring System by Invivo Corporation — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2015
Date Received
August 18, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

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  • K192200 — DynaCAD (October 9, 2019)
  • K182561 — UroNav (Version 3.0) (October 19, 2018)
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  • K153073 — UroNav (Version 2.0) (November 16, 2015)
  • K133030 — DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) (January 22, 2014)

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