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510(k) K082465

EVERON by Earlysense, Ltd. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2009
Date Received
August 27, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
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)
  • K100376 — EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 (August 6, 2010)
  • K092062 — EVERON 1.0 (May 24, 2010)

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