The following data is part of a premarket notification filed by Cardiac Science Corporation with the FDA for Powerheart Aed G3, Model 9390e, Powerheart Aed G3 Automatic, Model 9390a.
| Device ID | K091943 |
| 510k Number | K091943 |
| Device Name: | POWERHEART AED G3, MODEL 9390E, POWERHEART AED G3 AUTOMATIC, MODEL 9390A |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE CORPORATION 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Contact | Beverly Magrane |
| Correspondent | Beverly Magrane CARDIAC SCIENCE CORPORATION 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-30 |
| Decision Date | 2009-09-10 |
| Summary: | summary |