The following data is part of a premarket notification filed by Medical Predictive Science Corporation with the FDA for Hero Symphony, Hero Es, Hero Solo/duet.
| Device ID | K180242 |
| 510k Number | K180242 |
| Device Name: | HeRO Symphony, HeRO ES, HeRO Solo/duet |
| Classification | Electrocardiograph |
| Applicant | Medical Predictive Science Corporation 2246 Ivy Rd Suite 17 Charlottesville, VA 22903 |
| Contact | Will King |
| Correspondent | Will King Medical Predictive Science Corporation 2246 Ivy Rd Suite 17 Charlottesville, VA 22903 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-29 |
| Decision Date | 2018-02-28 |
| Summary: | summary |