The following data is part of a premarket notification filed by Heartsine Technologies, Inc. with the FDA for Samaritan Pad Pak Defibrillation Electrode, Model Spp-301.
| Device ID | K042088 |
| 510k Number | K042088 |
| Device Name: | SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | HEARTSINE TECHNOLOGIES, INC. 940 CALLE AMANECER, SUITE E San Clemente, CA 92673 |
| Contact | William J Smirles |
| Correspondent | William J Smirles HEARTSINE TECHNOLOGIES, INC. 940 CALLE AMANECER, SUITE E San Clemente, CA 92673 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-03 |
| Decision Date | 2004-09-02 |
| Summary: | summary |