510(k) Premarket Notification

• Device Classification Name: accessories, pump, infusion
• 510(K) Number: K120314
• Device Name: WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
• Applicant: WELLDOC, INC; 1501 saint paul street; suite 118; baltimore, MD 21202
• Contact: lauren bronich-hall
• Regulation Number: 880.5725
• Classification Product Code: MRZ
• Subsequent Product Code: LNX
• Date Received: 02/01/2012
• Decision Date: 02/24/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: General Hospital
• Review Advisory Committee: General Hospital
• statement: statement
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No