Cassette, Audio Tape

Device Code: 1024

Product Code(s): MCU

Device Classification Information

Device Type ID1024
Device NameCassette, Audio Tape
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Interventional Cardiology Devices Branch (ICDB)
Submission Type510(k)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeMCU
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1024
DeviceCassette, Audio Tape
Product CodeMCU
TPLC Last Update: 2019-04-02 19:46:47

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