The following data is part of a premarket notification filed by Heart Sync Inc. with the FDA for Heart Sync Pediatric Physio Aed Pad.
| Device ID | K120536 |
| 510k Number | K120536 |
| Device Name: | HEART SYNC PEDIATRIC PHYSIO AED PAD |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | HEART SYNC INC. 8870 RAVELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm HEART SYNC INC. 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-22 |
| Decision Date | 2012-08-06 |
| Summary: | summary |