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510(k) K151006

EarlySense Central Display Station (CDS) by Earlysense, Ltd. — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2015
Date Received
April 15, 2015
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 Earlysense, Ltd.

  • K171836 — EarlySense Bed Sensing Unit (January 4, 2018)
  • K152911 — EarlySense Insight Sytem (May 6, 2016)
  • 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)
  • K110521 — EVERON CENTRAL DISPLAY STATION (CDS) (April 19, 2011)
  • 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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  • K231506 — Current Health System (August 24, 2023)
  • K223567 — CNS-2101 Central Monitor (July 31, 2023)