Home / 510(k) Clearances / K091481

510(k) K091481

EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM by Eps Bio Technology Corp. — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2009
Date Received
May 19, 2009
Clearance Type
Special
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 Eps Bio Technology Corp.

  • K201258 — EASYMAX Tag Self-Monitoring Blood Glucose System (September 1, 2021)
  • K190189 — MDT2 BLE Self-Monitoring Blood Glucose System (November 1, 2019)
  • K182057 — EasyMax BT Self-Monitoring Blood Glucose System (August 24, 2018)
  • K133537 — EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUC (April 28, 2014)
  • K133389 — EM40 SELF-MONITORING BLOOD GLUCOSE SYSTEM (April 15, 2014)
  • K133647 — EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM (February 27, 2014)
  • K121207 — EASYMAX MU SELF MONITORING BLOOD GLUCOSE SYSTEM, EASYMAX MU PRO SELF MONITORING (May 18, 2012)
  • K113243 — EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM (March 28, 2012)
  • K112901 — EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD GLUCOSE (December 23, 2011)
  • K111728 — EMV3 SELF MONITORING BLOOD GLUCOSE SYSTEM, EMV3 PRO SELF MONITORING BLOOD GLUCOS (September 16, 2011)

Other clearances for product code NBW

  • 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)
  • K231192 — RIGHTEST Blood Glucose Monitoring System Max Tel (January 19, 2024)
  • K233058 — VivaChek Link Plus Blood Glucose Monitoring System (December 22, 2023)