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510(k) K082521

EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM by Card Guard Scientific Survival , Ltd. — Product Code NBW

K082521 is an FDA 510(k) premarket notification submitted by Card Guard Scientific Survival , Ltd. for the device "EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on January 16, 2009. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Card Guard Scientific Survival , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2009
Date Received
September 2, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Card Guard Scientific Survival , Ltd.

  • K111745 — KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER (August 1, 2011)
  • 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)
  • 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 NBW

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  • K262116 — TRUE METRIX Self Monitoring Blood Glucose System (July 23, 2026)
  • K250085 — On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK (October 10, 2025)
  • K243060 — TeleRPM Gen2 Blood Glucose Monitoring System (January 30, 2025)
  • K240637 — RIGHTEST Blood Glucose Monitoring System Max Tel (November 4, 2024)
  • K240640 — Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitori (October 8, 2024)
  • K241787 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Gluc (August 27, 2024)
  • K222126 — VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose (August 16, 2024)
  • K241304 — WaveSense Jazz Blood Glucose Monitoring System (June 6, 2024)
  • K231679 — CONTOUR® PLUS BLUE Blood Glucose Monitoring System (February 23, 2024)

FDA data resources