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510(k) K100376

EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 by Earlysense, Ltd. — Product Code MSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2010
Date Received
February 12, 2010
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)
  • 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)
  • K110521 — EVERON CENTRAL DISPLAY STATION (CDS) (April 19, 2011)
  • K092062 — EVERON 1.0 (May 24, 2010)
  • K082465 — EVERON (March 25, 2009)

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