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510(k) Data Aggregation
K Number
K100567Device Name
PEARL DIABETES MANAGEMENT SYSTEM
Manufacturer
M2 GROUP HOLDINGS, INC.
Date Cleared
2011-05-10
(435 days)
Product Code
LZG
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
M2 GROUP HOLDINGS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the continuous, subcutaneous delivery of insulin at programmable basal and bolus rates for the management of diabetes mellitus in adult patients requiring insulin.
Device Description
The Pearl Diabetes Management System is a continuous, programmable insulin delivery system. It consists of a controller, a single use pump body, a single use adapter and associated accessories. The controller unit has a user interface to program delivery parameters for basal and bolus insulin delivery and attaches to the pump body. The pump body provides the drive mechanism and battery power for pre-filled insulin cartridges. The adapter connects the insulin cartridge to the infusion set and contains the occlusion sensor.
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