The following data is part of a premarket notification filed by Cardioinsight Technologies, Inc with the FDA for Cardioinsight Cardiac Mapping System.
| Device ID | K162440 |
| 510k Number | K162440 |
| Device Name: | CardioInsight Cardiac Mapping System |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | CARDIOINSIGHT TECHNOLOGIES, INC 11000 CEDAR AVE SUITE 210 Cleveland, OH 44106 |
| Contact | Laurie Lewandowski |
| Correspondent | Laurie Lewandowski MEDTRONIC (OWNER/OPERATOR) 8200 CORAL SEA ST NE Mounds View, MN 55112 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-31 |
| Decision Date | 2016-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169723689 | K162440 | 000 |
| 00643169723672 | K162440 | 000 |
| 00643169723665 | K162440 | 000 |
| 00643169723658 | K162440 | 000 |
| 00643169723603 | K162440 | 000 |
| 00763000045456 | K162440 | 000 |
| 00763000045449 | K162440 | 000 |
| 00763000045432 | K162440 | 000 |
| 00763000045425 | K162440 | 000 |