The following data is part of a premarket notification filed by Cardiac Science with the FDA for Powerheart Aed G3, Model 9300.
| Device ID | K031987 |
| 510k Number | K031987 |
| Device Name: | POWERHEART AED G3, MODEL 9300 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE 5474 FELTL RD. Minneapolis, MN 55343 |
| Contact | Kenneth Olson |
| Correspondent | Kenneth Olson CARDIAC SCIENCE 5474 FELTL RD. Minneapolis, MN 55343 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-27 |
| Decision Date | 2003-07-30 |
| Summary: | summary |