The following data is part of a premarket notification filed by Cardiac Science Corporation with the FDA for Powerheart Aed G3 Semi-automatic, Powerheart Aed G3 Automatic, Powerheart Aed G3 Pro, Powerheart Aed G3 Plus.
| Device ID | K102496 |
| 510k Number | K102496 |
| Device Name: | POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE CORPORATION 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Contact | Kathleen Roberts |
| Correspondent | Kathleen Roberts 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 | 2010-08-31 |
| Decision Date | 2011-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812394021345 | K102496 | 000 |
| 00812394021017 | K102496 | 000 |
| 00812394021000 | K102496 | 000 |
| 00812394020928 | K102496 | 000 |
| 00812394020911 | K102496 | 000 |
| 00812394020898 | K102496 | 000 |
| 00812394020881 | K102496 | 000 |
| 00812394020874 | K102496 | 000 |
| 00812394020867 | K102496 | 000 |
| 00812394020379 | K102496 | 000 |
| 00812394020362 | K102496 | 000 |
| 00812394020331 | K102496 | 000 |
| 00812394021024 | K102496 | 000 |
| 00812394021031 | K102496 | 000 |
| 00812394021048 | K102496 | 000 |
| 00812394021321 | K102496 | 000 |
| 00812394021147 | K102496 | 000 |
| 00812394021130 | K102496 | 000 |
| 00812394021123 | K102496 | 000 |
| 00812394021116 | K102496 | 000 |
| 00812394021109 | K102496 | 000 |
| 00812394021093 | K102496 | 000 |
| 00812394021086 | K102496 | 000 |
| 00812394021079 | K102496 | 000 |
| 00812394021062 | K102496 | 000 |
| 00812394021055 | K102496 | 000 |
| 00812394020232 | K102496 | 000 |