510(k) K182149
- Device
- FFRangio System
- Applicant
- CathWorks Ltd
- 510(k) number
- K182149
- Product code
- QEK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-12-19
- Date received
- 2018-08-08
- Regulation
- 870.1415
- Classification name
- Angiographic Coronary Vascular Physiologic Simulation Software
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Miriam Ivenshitz
- Address
- 3 Rapaport St. Kfar-Saba IL 4465141 4465141
FDA Registration Numbers#
- 3015192387
- 3004016520
- 3014129161
Source Documents#
Other 510(k) Records For Product Code QEK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192442 | FFRangio | Cathworks, Ltd. | 2019-12-09 |
Legacy Summary#
summary
FDA Review#
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