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510(k) K100066

Device
DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
Applicant
WELLDOC, INC
510(k) number
K100066
Product code
LNX  
Decision
Substantially Equivalent (SESE)
Decision date
2010-07-15
Date received
2010-01-11
Regulation
510(k) Premarket Notification
Classification name
Medical Computers And Software
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MALINDA PEEPLES
Address
1501 Saint Paul St. Suite 118 Baltimore MD US 21202 21202

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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