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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Biological Stains
CFR Sub-Part
Clinical Chemistry Test Systems
CFR Sub-Part
Clinical Laboratory Instruments
CFR Sub-Part
Clinical Toxicology Test Systems
CFR Sub-Part
Diagnostic Devices
CFR Sub-Part
NDC
Calculator, Drug Dose
2
Product Code
K
21
1160
EndoTool SubQ 2.1
2
Cleared 510(K)
K
20
3434
BlueStar Rx
2
Cleared 510(K)
K
20
2596
Insulia Diabetes Management Companion
2
Cleared 510(K)
K
20
1619
EndoTool IV System
2
Cleared 510(K)
K
20
1337
InPen System
2
Cleared 510(K)
K
20
0443
EndoTool IV 1.10
2
Cleared 510(K)
K
19
0487
InPen Dose Calculator
2
Cleared 510(K)
K
19
2841
InPen System
2
Cleared 510(K)
K
18
1916
d-Nav System
2
Cleared 510(K)
K
18
0366
EndoTool SubQ
2
Cleared 510(K)
K
18
1327
InPen Dose Calculator
2
Cleared 510(K)
K
17
1450
Glooko Mobile Insulin Dosing System
2
Cleared 510(K)
K
17
2177
Insulia Diabetes Management Companion
2
Cleared 510(K)
K
16
3664
Health-e-Connect System with IDA
2
Cleared 510(K)
K
15
2300
Glucommander
2
Cleared 510(K)
K
17
0669
Insulia Diabetes Management Companion
2
Cleared 510(K)
K
16
0673
Insulin Algorithms System
2
Cleared 510(K)
K
17
1230
My Dose Coach
2
Cleared 510(K)
K
16
3099
My Dose Coach
2
Cleared 510(K)
K
16
1865
iSage Rx (iSage Rx Basal Insulin Titration)
2
Cleared 510(K)
K
16
0949
Go Dose System
2
Cleared 510(K)
K
16
1433
Insulia Diabetes Management Companion
2
Cleared 510(K)
K
15
0910
ACCU-CHEK Connect Diabetes Management App
2
Cleared 510(K)
K
14
2918
EndoTool SubQ
2
Cleared 510(K)
K
14
1929
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
2
Cleared 510(K)
K
14
2123
REACH ACCESS TELEMEDICINE DOSE CALCULATOR
2
Cleared 510(K)
K
14
1321
GLUCOSTABILIZER INSULIN DOSING CALCULATOR
2
Cleared 510(K)
K
13
2547
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
2
Cleared 510(K)
K
12
1542
PICIS WEIGHT BASED DOSE CONVERTER
2
Cleared 510(K)
K
11
3853
G+ SYSTEM
2
Cleared 510(K)
K
10
1344
G+ SYSTEM
2
Cleared 510(K)
K
08
2512
INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER
2
Cleared 510(K)
K
08
1388
GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM
2
Cleared 510(K)
K
07
1713
CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR
2
Cleared 510(K)
K
05
3137
ENDOTOOL DRUG DOSE CALCULATOR
2
Cleared 510(K)
K
06
1110
GLUCOMMANDER PLUS
2
Cleared 510(K)
K
01
1571
TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
2
Cleared 510(K)
K
00
0418
PDT DOSECALCULATOR, MODEL 80000
2
Cleared 510(K)
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Immunological Test Systems
CFR Sub-Part
Microbiology Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Pathology Instrumentation and Accessories
CFR Sub-Part
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 2 June 2023 at 11:04 pm
CH
/
diagnostic-devices
/
NDC
/
K141929
View Source
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K141929
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTICS CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/16/2015
Days to Decision
243 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Biological Stains
Clinical Chemistry Test Systems
Clinical Laboratory Instruments
Clinical Toxicology Test Systems
Diagnostic Devices
NDC
Calculator, Drug Dose
K
21
1160
EndoTool SubQ 2.1
K
20
3434
BlueStar Rx
K
20
2596
Insulia Diabetes Management Companion
K
20
1619
EndoTool IV System
K
20
1337
InPen System
K
20
0443
EndoTool IV 1.10
K
19
0487
InPen Dose Calculator
K
19
2841
InPen System
K
18
1916
d-Nav System
K
18
0366
EndoTool SubQ
K
18
1327
InPen Dose Calculator
K
17
1450
Glooko Mobile Insulin Dosing System
K
17
2177
Insulia Diabetes Management Companion
K
16
3664
Health-e-Connect System with IDA
K
15
2300
Glucommander
K
17
0669
Insulia Diabetes Management Companion
K
16
0673
Insulin Algorithms System
K
17
1230
My Dose Coach
K
16
3099
My Dose Coach
K
16
1865
iSage Rx (iSage Rx Basal Insulin Titration)
K
16
0949
Go Dose System
K
16
1433
Insulia Diabetes Management Companion
K
15
0910
ACCU-CHEK Connect Diabetes Management App
K
14
2918
EndoTool SubQ
K
14
1929
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
K
14
2123
REACH ACCESS TELEMEDICINE DOSE CALCULATOR
K
14
1321
GLUCOSTABILIZER INSULIN DOSING CALCULATOR
K
13
2547
ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
K
12
1542
PICIS WEIGHT BASED DOSE CONVERTER
K
11
3853
G+ SYSTEM
K
10
1344
G+ SYSTEM
K
08
2512
INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER
K
08
1388
GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM
K
07
1713
CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR
K
05
3137
ENDOTOOL DRUG DOSE CALCULATOR
K
06
1110
GLUCOMMANDER PLUS
K
01
1571
TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
K
00
0418
PDT DOSECALCULATOR, MODEL 80000
General Hospital and Personal Use Therapeutic Devices
Immunological Test Systems
Microbiology Devices
Miscellaneous
Pathology Instrumentation and Accessories
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
CH
/
diagnostic-devices
/
NDC
/
K141929
View Source
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K141929
510(k) Type
Traditional
Applicant
ROCHE DIAGNOSTICS CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/16/2015
Days to Decision
243 days
Submission Type
Summary