DXR — Ballistocardiograph Class II
FDA product code DXR covers "Ballistocardiograph", a Class II medical device regulated under 21 CFR 870.2320. Submissions are reviewed by the Cardiovascular panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DXR
- Device Class
- Class II
- Regulation Number
- 870.2320
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243566 | Cardiosense | CardioTag | Jul 22, 2025 |
| K160656 | Corsens Medical | CorSens | Nov 21, 2016 |
| K081603 | Heartforce Medical | DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 | Jul 24, 2009 |
| K870442 | Vital Science | QUANTASCOPE | Aug 11, 1987 |
| K863508 | Frantz Medical Development | FRANTZ MEDICAL ELECTRODE | Feb 6, 1987 |