NDC · Class II · 21 CFR 868.1890

FDA Product Code NDC: Calculator, Drug Dose

Leading manufacturers include Voluntis Sa., Companion Medical, Inc. and Glytec, LLC.

55
Total
55
Cleared
158d
Avg days
1986
Since
55 devices
25–48 of 55
Cleared Sep 18, 2017
Health-e-Connect System with IDA
K163664
Alr Technologies
General Hospital · 265d
Cleared Aug 04, 2017
Glucommander
K152300
Glytec, LLC
General Hospital · 721d
Cleared Jun 19, 2017
Insulia Diabetes Management Companion
K170669
Voluntis Sa.
General Hospital · 105d
Cleared Jun 07, 2017
Insulin Algorithms System
K160673
Insulin Algorithms
General Hospital · 454d
Cleared May 26, 2017
My Dose Coach
K171230
Sanofi
General Hospital · 29d
Cleared Mar 22, 2017
My Dose Coach
K163099
Sanofi, Inc.
General Hospital · 135d
Cleared Mar 07, 2017
iSage Rx (iSage Rx Basal Insulin Titration)
K161865
Isag Rx, Inc.
General Hospital · 243d
Cleared Dec 22, 2016
Go Dose System
K160949
Eli Lilly and Company
General Hospital · 261d
Cleared Nov 09, 2016
Insulia Diabetes Management Companion
K161433
Voluntis Sa.
General Hospital · 169d
Cleared Jun 03, 2015
ACCU-CHEK Connect Diabetes Management App
K150910
Roche Diabetes Care, Inc.
General Hospital · 61d
Cleared Apr 24, 2015
EndoTool SubQ
K142918
Monarch Medical Technologies
General Hospital · 199d
Cleared Mar 16, 2015
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
K141929
Roche Diagnostics Corporation
General Hospital · 243d
Cleared Sep 24, 2014
REACH ACCESS TELEMEDICINE DOSE CALCULATOR
K142123
Reach Health, Inc.
General Hospital · 51d
Cleared Sep 15, 2014
GLUCOSTABILIZER INSULIN DOSING CALCULATOR
K141321
Medical Decision Network
General Hospital · 118d
Cleared Apr 17, 2014
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
K132547
Monarch Medical Technologies
General Hospital · 247d
Cleared Aug 27, 2012
PICIS WEIGHT BASED DOSE CONVERTER
K121542
Picis, Inc.
General Hospital · 95d
Cleared May 08, 2012
G+ SYSTEM
K113853
Glytec, LLC
General Hospital · 131d
Cleared Jun 28, 2010
G+ SYSTEM
K101344
Glytec, LLC (Formally Known AS Glucotec, Inc.)
General Hospital · 46d
Cleared Nov 07, 2008
INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER
K082512
Dimensional Dosing Systems, Inc.
General Hospital · 70d
Cleared Aug 21, 2008
GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM
K081388
Pronia Medical System, LLC
General Hospital · 94d
Cleared Oct 12, 2007
CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR
K071713
Medical Decisions Network
General Hospital · 112d
Cleared Jun 14, 2006
ENDOTOOL DRUG DOSE CALCULATOR
K053137
MD Scientific, LLC
General Hospital · 217d
Cleared Jun 07, 2006
GLUCOMMANDER PLUS
K061110
Collaborativemed, LLC
General Hospital · 48d
Cleared Apr 08, 2005
ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
K043529
Roche Diagnostics Corp.
General Hospital · 108d