Batteries, Rechargeable, For Class 2 Devices

Device Code: 1035

Product Code(s): MOX

Device Classification Information

Device Type ID1035
Device NameBatteries, Rechargeable, For Class 2 Devices
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Implantable Electrophysical Devices Branch (IEDB)
Submission Type510(k)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeMOX
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1035
DeviceBatteries, Rechargeable, For Class 2 Devices
Product CodeMOX
Device Problems
Complete Loss Of Power
1
Battery
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 19:47:05

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