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510(k) K113176

MYSENSE HEART by Cardiac Science Corporation — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2011
Date Received
October 28, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Cardiac Science Corporation

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  • K093211 — CARECENTER MD (June 3, 2010)
  • K091943 — POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A (September 10, 2009)
  • K082090 — 9131 DEFIBRILLATION ELECTRODES (December 12, 2008)
  • K082173 — Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S (August 26, 2008)
  • K060934 — MODIFICATION TO POWERHEART ECD (May 15, 2006)
  • K060167 — ATRIA 3100, ATRIA 6100 (April 19, 2006)

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