510(k) K243566
- Device
- CardioTag™
- Applicant
- Cardiosense, Inc.
- 510(k) number
- K243566
- Product code
- DXR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-22
- Date received
- 2024-11-18
- Regulation
- 870.2320
- Classification name
- Ballistocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Arezou Azar
- Address
- 400 N Aberdeen St. Suite 900 Chicago IL US 60642 60642
Source Documents#
Other 510(k) Records For Product Code DXR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160656 | CorSens | Corsens Medical , Ltd. | 2016-11-21 |
| K081603 | DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 | Heartforce Medical, Inc. | 2009-07-24 |
| K870442 | QUANTASCOPE | Vital Science Corp. | 1987-08-11 |
| K863508 | FRANTZ MEDICAL ELECTRODE | Frantz Medical Development, Ltd. | 1987-02-06 |