| Device Type ID | 816 |
| Device Name | Transmitters And Receivers, Electrocardiograph, Telephone |
| Regulation Description | Telephone Electrocardiograph Transmitter And Receiver. |
| 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 | 870.2920 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DXH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 816 |
| Device | Transmitters And Receivers, Electrocardiograph, Telephone |
| Product Code | DXH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Telephone Electrocardiograph Transmitter And Receiver. |
| CFR Regulation Number | 870.2920 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED FLUIDICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALIVECOR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CARDIOCOMM SOLUTIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COMMWELL R&D LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MAKROMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEGA ELECTRONICS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RHYTHMEDIX, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VERILY LIFE SCIENCES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VITASYSTEMS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Failure To Fire | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Alivecor SFO | III | Feb-18-2015 |
| 2 | Spacelabs Healthcare Inc | II | Oct-30-2015 |