The following data is part of a premarket notification filed by Cardiac Science Corporation with the FDA for Powerheart G5 Aed.
| Device ID | K122758 |
| 510k Number | K122758 |
| 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 | 2012-09-10 |
| Decision Date | 2014-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812394021314 | K122758 | 000 |
| 00812394020942 | K122758 | 000 |
| 00812394020904 | K122758 | 000 |
| 00812394020560 | K122758 | 000 |
| 00812394020539 | K122758 | 000 |
| 00812394020515 | K122758 | 000 |
| 00812394020492 | K122758 | 000 |
| 00812394020171 | K122758 | 000 |
| 00812394020164 | K122758 | 000 |
| 00812394020157 | K122758 | 000 |
| 00812394020140 | K122758 | 000 |
| 00812394020133 | K122758 | 000 |
| 00812394020126 | K122758 | 000 |
| 00812394020959 | K122758 | 000 |
| 00812394020980 | K122758 | 000 |
| 00812394020997 | K122758 | 000 |
| 00812394021307 | K122758 | 000 |
| 00812394021291 | K122758 | 000 |
| 00812394021277 | K122758 | 000 |
| 00812394021260 | K122758 | 000 |
| 00812394021253 | K122758 | 000 |
| 00812394021239 | K122758 | 000 |
| 00812394021222 | K122758 | 000 |
| 00812394021215 | K122758 | 000 |
| 00812394021192 | K122758 | 000 |
| 00812394021185 | K122758 | 000 |
| 00812394021178 | K122758 | 000 |
| 00812394021154 | K122758 | 000 |
| 00812394020041 | K122758 | 000 |