The following data is part of a premarket notification filed by Cardioinsight Technologies, Inc with the FDA for Ecvue Mapping System.
| Device ID | K140497 |
| 510k Number | K140497 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-27 |
| Decision Date | 2014-11-19 |
| Summary: | summary |