FDA Product Code
FDA Product Code DXR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2320
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243566 | CardioTag | Cardiosense, Inc. | 2025-07-22 | Traditional | PDF ↗ |
| K160656 | CorSens | Corsens Medical , Ltd. | 2016-11-21 | Traditional | PDF ↗ |
| K081603 | DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 | Heartforce Medical, Inc. | 2009-07-24 | Traditional | PDF ↗ |
| K870442 | QUANTASCOPE | Vital Science Corp. | 1987-08-11 | Traditional | PDF ↗ |
| K863508 | FRANTZ MEDICAL ELECTRODE | Frantz Medical Development, Ltd. | 1987-02-06 | Traditional | PDF ↗ |
Product code DXR · Class II · Cardiovascular. Data: openFDA.