The following data is part of a premarket notification filed by Heartsine Technologies, Inc. with the FDA for Heartsine Samaritan Pad 350p.
| Device ID | K123881 |
| 510k Number | K123881 |
| Device Name: | HEARTSINE SAMARITAN PAD 350P |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | HEARTSINE TECHNOLOGIES, INC. 203 AIRPORT ROAD WEST BELFAST Northern, IE Bt3 9ed |
| Contact | James Mcguinness |
| Correspondent | James Mcguinness HEARTSINE TECHNOLOGIES, INC. 203 AIRPORT ROAD WEST BELFAST Northern, IE Bt3 9ed |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-17 |
| Decision Date | 2013-07-11 |
| Summary: | summary |