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510(k) K110521

EVERON CENTRAL DISPLAY STATION (CDS) by Earlysense, Ltd. — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2011
Date Received
February 23, 2011
Clearance Type
Special
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 Earlysense, Ltd.

  • K171836 — EarlySense Bed Sensing Unit (January 4, 2018)
  • K152911 — EarlySense Insight Sytem (May 6, 2016)
  • K151006 — EarlySense Central Display Station (CDS) (August 31, 2015)
  • K133661 — CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM (June 13, 2014)
  • K131379 — EARLYSENSE (December 18, 2013)
  • K121885 — EARLYSENSE CENTRAL DISPLAY SYSTEM (September 10, 2012)
  • K120465 — EARLYSENSE (EVERON) SYSTEM (June 8, 2012)
  • K100376 — EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 (August 6, 2010)
  • K092062 — EVERON 1.0 (May 24, 2010)
  • K082465 — EVERON (March 25, 2009)

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  • 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)