The following data is part of a premarket notification filed by Heartsine Technologies, Inc. with the FDA for Reduced Energy Pediatric Electrode Pads For The Samaritan Aed And Pad, Models Sde 251, Spp 351.
| Device ID | K052465 |
| 510k Number | K052465 |
| Device Name: | REDUCED ENERGY PEDIATRIC ELECTRODE PADS FOR THE SAMARITAN AED AND PAD, MODELS SDE 251, SPP 351 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | HEARTSINE TECHNOLOGIES, INC. 105 TERRY DR Newtown, PA 18940 |
| Contact | George Brdlik |
| Correspondent | George Brdlik HEARTSINE TECHNOLOGIES, INC. 105 TERRY DR Newtown, PA 18940 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-08 |
| Decision Date | 2006-12-12 |
| Summary: | summary |