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510(k) K111745

KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER by Card Guard Scientific Survival , Ltd. — Product Code DSH

K111745 is an FDA 510(k) premarket notification submitted by Card Guard Scientific Survival , Ltd. for the device "KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER". The FDA issued a decision of Substantially Equivalent on August 1, 2011. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Card Guard Scientific Survival , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2011
Date Received
June 21, 2011
Clearance Type
Special
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 Card Guard Scientific Survival , Ltd.

  • K110499 — CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (April 6, 2011)
  • K101703 — MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, (July 13, 2010)
  • K101639 — CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR (June 25, 2010)
  • K083174 — HEALTHEPOD (December 17, 2009)
  • K082521 — EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM (January 16, 2009)
  • K081257 — CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR (May 29, 2008)
  • K071995 — CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (December 18, 2007)
  • K061428 — PMP4 APPLICATION (October 16, 2006)
  • K061528 — SELFCHECK GLUCO (September 22, 2006)
  • K060911 — CG-6108 ARRHYTHMIA ECG EVENT RECORDER (August 22, 2006)

Other clearances for product code DSH

  • K260157 — LifeLens Physiological Monitor (July 9, 2026)
  • K252389 — Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) (April 23, 2026)
  • K253293 — VitaloJAK Clinic (Model 7100) (December 3, 2025)
  • K243650 — Zio® monitor (DFG0001) (August 15, 2025)
  • K243603 — AeviceMD (May 5, 2025)
  • K242583 — AT-Patch (ATP-C130/ATP-C70) (May 2, 2025)
  • K232670 — HiCardi+ H100 (September 20, 2024)
  • K233906 — S-Patch (S-Patch ExL) (February 16, 2024)
  • K231104 — ABPMpro (November 27, 2023)
  • K233110 — Carnation Ambulatory Monitor (November 22, 2023)

FDA data resources