Device Type ID | 760 |
Device Name | Adaptor, Lead Switching, Electrocardiograph |
Regulation Description | Electrocardiograph Lead Switching Adaptor. |
Regulation Medical Specialty | Cardiovascular |
Review Panel | Cardiovascular |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
Submission Type | 510(k) |
CFR Regulation Number | 870.2350 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | DRW |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 760 |
Device | Adaptor, Lead Switching, Electrocardiograph |
Product Code | DRW |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Electrocardiograph Lead Switching Adaptor. |
CFR Regulation Number | 870.2350 [🔎] |