The following data is part of a premarket notification filed by Medical Predictive Science Corp. with the FDA for Hero, Version 2.0.
| Device ID | K081473 |
| 510k Number | K081473 |
| Device Name: | HERO, VERSION 2.0 |
| Classification | Electrocardiograph |
| Applicant | MEDICAL PREDICTIVE SCIENCE CORP. 2246 IVY RD., SUITE 17 Charlottesville, VA 22903 |
| Contact | William E King |
| Correspondent | William E King MEDICAL PREDICTIVE SCIENCE CORP. 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 | 2008-05-27 |
| Decision Date | 2008-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865536000234 | K081473 | 000 |
| 00865536000227 | K081473 | 000 |
| 00865536000210 | K081473 | 000 |