The following data is part of a premarket notification filed by Cardiac Science, Inc. with the FDA for Powerheart Aecd.
| Device ID | K993533 |
| 510k Number | K993533 |
| Device Name: | POWERHEART AECD |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE, INC. 16931 MILLIKAN AVE. Irvine, CA 92606 |
| Contact | Stan E Tillman |
| Correspondent | Stan E Tillman CARDIAC SCIENCE, INC. 16931 MILLIKAN AVE. Irvine, CA 92606 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-19 |
| Decision Date | 2000-01-24 |
| Summary: | summary |