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510(k) K141706

ECARE COORDINATOR (ECC) by Visicu, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2014
Date Received
June 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

Other clearances by Visicu, Inc.

  • K211046 — eCareManager 4.5 (June 3, 2022)
  • K171322 — eCareManager 4.1 (August 3, 2017)
  • K171029 — eCareCoordinator (July 14, 2017)
  • K153156 — eCareManager 4.0.1 (September 30, 2016)
  • 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)

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