The following data is part of a premarket notification filed by Cardiac Science, Inc. with the FDA for Powerheart Cardiac Rhythm Module.
| Device ID | K012197 |
| 510k Number | K012197 |
| Device Name: | POWERHEART CARDIAC RHYTHM MODULE |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE, INC. 5420 FELTL RD. Minnetonka, MN 55343 |
| Contact | Sew-wah Tay |
| Correspondent | Sew-wah Tay CARDIAC SCIENCE, INC. 5420 FELTL RD. Minnetonka, MN 55343 |
| Product Code | MKJ |
| Subsequent Product Code | DRO |
| Subsequent Product Code | LDD |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-13 |
| Decision Date | 2001-11-16 |
| Summary: | summary |