510(k) K160656
- Device
- CorSens
- Applicant
- CorSens Medical Ltd.
- 510(k) number
- K160656
- Product code
- DXR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-11-21
- Date received
- 2016-03-08
- 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
- No
Applicant Contact#
- Contact
- Yoram Levy
- Address
- 3 Azrieli Center Triangular Tower 33rd Floor 132 Menachem Begin Rd. Tel Aviv IL 6702301 6702301
Source Documents#
Other 510(k) Records For Product Code DXR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243566 | CardioTag™ | Cardiosense, Inc. | 2025-07-22 |
| 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 |
Legacy Summary#
summary
FDA Review#
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