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510(k) K152911

EarlySense Insight Sytem by Earlysense, Ltd. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2016
Date Received
October 2, 2015
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)
  • 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)
  • K082465 — EVERON (March 25, 2009)

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