Home / 510(k) Clearances / K101597

510(k) K101597

WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 by Agamatrix — Product Code NBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2010
Date Received
June 8, 2010
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 Agamatrix

  • K241304 — WaveSense Jazz Blood Glucose Monitoring System (June 6, 2024)
  • K161834 — One Drop Blood Glucose Monitoring System (November 30, 2016)
  • K152365 — AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System (April 21, 2016)
  • K132821 — AGAMATRIX HEALTH MANAGER (November 20, 2013)
  • K130535 — IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION (April 17, 2013)
  • K103544 — IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, R (December 7, 2011)
  • K083265 — JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381 (February 3, 2009)
  • K073573 — WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM (January 30, 2008)
  • K072413 — MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEM (September 27, 2007)
  • K071393 — JAZZ BLOOD GLUCOSE MONITORING SYSTEM (July 20, 2007)

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)