| Device Type ID | 842 |
| Device Name | Transducer, Ultrasonic |
| Regulation Description | Ultrasonic Transducer. |
| 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 | 870.2880 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JOP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 842 |
| Device | Transducer, Ultrasonic |
| Product Code | JOP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ultrasonic Transducer. |
| CFR Regulation Number | 870.2880 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KOVEN TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biosound Esaote, Inc. | II | Aug-08-2014 |