The following data is part of a premarket notification filed by Cardiac Science, Inc. with the FDA for Powerheart Aecd.
| Device ID | K970741 |
| 510k Number | K970741 |
| Device Name: | POWERHEART AECD |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE, INC. 1176 MAIN STREET, BLDG. C Irvine, CA 92614 |
| Contact | Raymond Cohen |
| Correspondent | Raymond Cohen CARDIAC SCIENCE, INC. 1176 MAIN STREET, BLDG. C Irvine, CA 92614 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-28 |
| Decision Date | 1997-10-16 |
| Summary: | summary |