The following data is part of a premarket notification filed by Heart Sync Llc with the FDA for Heart Sync Pediatric, Model Ped-100.
| Device ID | K081442 |
| 510k Number | K081442 |
| Device Name: | HEART SYNC PEDIATRIC, MODEL PED-100 |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | HEART SYNC LLC 5643 PLYMOUTH ROAD Ann Arbor, MI 48105 |
| Contact | Stephen Shulman |
| Correspondent | Stephen Shulman HEART SYNC LLC 5643 PLYMOUTH ROAD Ann Arbor, MI 48105 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-22 |
| Decision Date | 2008-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040001421 | K081442 | 000 |
| 10304040001414 | K081442 | 000 |
| 10304040001407 | K081442 | 000 |
| 00815277023924 | K081442 | 000 |
| 00815277023887 | K081442 | 000 |
| 00815277023863 | K081442 | 000 |
| 20888277634944 | K081442 | 000 |
| 20888277634951 | K081442 | 000 |
| 20888277634937 | K081442 | 000 |