The following data is part of a premarket notification filed by Cardiac Science, Inc. with the FDA for Powerheart Aed G3 (model 9390e), Powerheart Aed G3 Automatic (model 9390a).
| Device ID | K052161 |
| 510k Number | K052161 |
| Device Name: | POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE, INC. 1900 MAIN ST., SUITE 700 Irvine, CA 92614 |
| Contact | Kenneth F Olson |
| Correspondent | Kenneth F Olson CARDIAC SCIENCE, INC. 1900 MAIN ST., SUITE 700 Irvine, CA 92614 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-09 |
| Decision Date | 2005-10-21 |
| Summary: | summary |