The following data is part of a premarket notification filed by Heartsine Technologies, Inc. with the FDA for Samaritan Pad 450p.
| Device ID | K142709 |
| 510k Number | K142709 |
| Device Name: | Samaritan PAD 450P |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | HEARTSINE TECHNOLOGIES, INC. 121 Friends Lane Suite 400 Newtown, PA 18940 |
| Contact | Paul Phillips |
| Correspondent | Mark Kramer Regulatory Strategies, Inc 808 E. Fox Lane Fox Point, WI 53217 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-22 |
| Decision Date | 2015-03-27 |
| Summary: | summary |