Ballistocardiograph
FDA product code DXR · Class II (moderate risk) · 21 CFR 870.2320 · Cardiovascular
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243566 | CardioTagDXR · Traditional | Cardiosense, Inc. | 07/22/2025SE |
| K160656 | CorSensDXR · Traditional | Corsens Medical , Ltd. | 11/21/2016SE |
| K081603 | Digital Ballistocardiograph, Model DGB 300DXR · Traditional | Heartforce Medical, Inc. | 07/24/2009SE |
| K870442 | QuantascopeDXR · Traditional | Vital Science Corp. | 08/11/1987SN |
| K863508 | Frantz Medical ElectrodeDXR · Traditional | Frantz Medical Development, Ltd. | 02/06/1987SE |