The following data is part of a premarket notification filed by Cardiac Science Corporation with the FDA for Modification To Powerheart Ecd.
| Device ID | K060934 |
| 510k Number | K060934 |
| Device Name: | MODIFICATION TO POWERHEART ECD |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE CORPORATION 3303 MONTE VILLA PKWY. Bothell, WA 98021 |
| Contact | Cheryl Shea |
| Correspondent | Cheryl Shea 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 | 2006-04-05 |
| Decision Date | 2006-05-15 |
| Summary: | summary |