The following data is part of a premarket notification filed by Invisionheart Inc. with the FDA for Invisionecg System.
| Device ID | K143436 |
| 510k Number | K143436 |
| Device Name: | InvisionECG System |
| Classification | Electrocardiograph |
| Applicant | InvisionHeart Inc. 121 17th Avenue South Nashville, TN 37203 |
| Contact | Michael Wurst |
| Correspondent | Thomas Kroenke Speed To Market, Inc. PO Box 3018 Nederland, CO 80466 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-01 |
| Decision Date | 2015-05-21 |
| Summary: | summary |