Device Type ID | 1024 |
Device Name | Cassette, Audio Tape |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
Submission Type | 510(k) |
FDA Device Classification | Class Unclassified Medical Device |
Product Code | MCU |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1024 |
Device | Cassette, Audio Tape |
Product Code | MCU |