| Device Type ID | 767 |
| Device Name | Recorder, Magnetic Tape, Medical |
| Regulation Description | Medical Magnetic Tape Recorder. |
| 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 | 870.2800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DSH |
| 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 | 767 |
| Device | Recorder, Magnetic Tape, Medical |
| Product Code | DSH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Medical Magnetic Tape Recorder. |
| CFR Regulation Number | 870.2800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANDON HEALTH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BARDY DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BRAEMAR CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARDIAC INSIGHT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DMS-SERVICE LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
IRHYTHM TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Use Of Device Problem | 70 |
Circuit Failure | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Device Operates Differently Than Expected | 1 |
Device Displays Incorrect Message | 1 |
No Apparent Adverse Event | 1 |
Incorrect Interpretation Of Signal | 1 |
Temperature Problem | 1 |
| Total Device Problems | 79 |