The following data is part of a premarket notification filed by Cardiac Science Corporation with the FDA for Powerheart G5 Aed.
| Device ID | K143714 |
| 510k Number | K143714 |
| Device Name: | Powerheart G5 AED |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE CORPORATION N7 W22025 Johnson Dr -- Waukesha, WI 53186 |
| Contact | Kathleen Roberts |
| Correspondent | Kathleen Roberts CARDIAC SCIENCE CORPORATION N7 W22025 Johnson Dr -- Waukesha, WI 53186 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-29 |
| Decision Date | 2015-05-04 |
| Summary: | summary |