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510(k) K211046

eCareManager 4.5 by Visicu, Inc. — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2022
Date Received
April 8, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Network And Communication, Physiological Monitors
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Visicu, Inc.

  • K171322 — eCareManager 4.1 (August 3, 2017)
  • K171029 — eCareCoordinator (July 14, 2017)
  • K153156 — eCareManager 4.0.1 (September 30, 2016)
  • K141706 — ECARE COORDINATOR (ECC) (September 9, 2014)
  • K012171 — MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS (July 24, 2001)
  • K001972 — ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK (October 27, 2000)

Other clearances for product code MSX

  • K243270 — TigerConnect Alarm Management (September 30, 2025)
  • K242728 — BeneVision Central Monitoring System (July 31, 2025)
  • K242750 — Central Station (June 5, 2025)
  • K242842 — ANNE View, Central Hub (January 8, 2025)
  • K241397 — Hinscope (November 14, 2024)
  • K233834 — Infinity Gateway Suite (July 12, 2024)
  • K233418 — Biofourmis Everion+ (G2) (May 9, 2024)
  • K232548 — Corsano CardioWatch 287-2 System (March 22, 2024)
  • K231506 — Current Health System (August 24, 2023)
  • K223567 — CNS-2101 Central Monitor (July 31, 2023)