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510(k) K233446

AMC Health CareConsole by Amc Health — Product Code MWI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2024
Date Received
October 19, 2023
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 Amc Health

  • K151839 — AMC Health VitalCaregiving System (September 9, 2016)

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  • 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)
  • K240236 — Happy Ring Health Monitoring System (September 24, 2024)
  • K233354 — WVSM Pro (Series) (500-0030-XX) (June 26, 2024)
  • K232111 — NeoBeat, NeoBeat Mini (June 25, 2024)