Batteries, Rechargeable, For Class 3 Devices

Device Code: 1036

Product Code(s): MOY

Device Classification Information

Device Type ID1036
Device NameBatteries, Rechargeable, For Class 3 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 CodeMOY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1036
DeviceBatteries, Rechargeable, For Class 3 Devices
Product CodeMOY
Device Problems
Battery Problem
2
Failure To Run On Battery
1
No Display / Image
1
Use Of Device Problem
1
Pumping Stopped
1
Total Device Problems 6
TPLC Last Update: 2019-04-02 19:47:06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.