The following data is part of a premarket notification filed by Cardioinsight Technologies, Inc. with the FDA for Ecvue Mapping System.
| Device ID | K150990 |
| 510k Number | K150990 |
| Device Name: | ECVUE Mapping System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | CardioInsight Technologies, Inc. 11000 Cedar Ave. Suite 210 Cleveland, OH 44106 |
| Contact | Christina V Vacca |
| Correspondent | Christina V Vacca CardioInsight Technologies, Inc. 11000 Cedar Ave. Suite 210 Cleveland, OH 44106 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-15 |
| Decision Date | 2015-07-02 |
| Summary: | summary |