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510(k) K212227

Philips MR Patient Care Portal by Invivo Corporation — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2021
Date Received
July 16, 2021
Clearance Type
Traditional
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

Other clearances by Invivo Corporation

  • K213766 — dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5 (December 23, 2021)
  • K212175 — DynaCAD (August 2, 2021)
  • K193403 — UroNav System (December 27, 2019)
  • K192200 — DynaCAD (October 9, 2019)
  • K182561 — UroNav (Version 3.0) (October 19, 2018)
  • K162177 — dS FootAnkle I6CH 1.5T Coil (September 14, 2016)
  • K162001 — 1.5T and 3.0T 16 CH GE Shoulder Coils (August 31, 2016)
  • K152330 — Expression MR400 MRI Patient Monitoring System (December 23, 2015)
  • K153073 — UroNav (Version 2.0) (November 16, 2015)
  • K133030 — DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) (January 22, 2014)

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  • K242737 — Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (June 6, 2025)
  • K241958 — WARD-CSS (v1.2.x) (February 14, 2025)
  • K243146 — iCare APP (February 3, 2025)
  • K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (December 20, 2024)
  • K243216 — Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) (December 10, 2024)
  • K233446 — AMC Health CareConsole (September 27, 2024)
  • K240236 — Happy Ring Health Monitoring System (September 24, 2024)
  • K233354 — WVSM Pro (Series) (500-0030-XX) (June 26, 2024)