The following data is part of a premarket notification filed by Cardiac Science, Inc. with the FDA for Pediatric Attenuated Defibrillation Electrodes, Model 9730, Powederheart Aed, Model 9200/9210.
| Device ID | K022929 |
| 510k Number | K022929 |
| Device Name: | PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | CARDIAC SCIENCE, INC. 16931 MILLIKAN AVE. Irvine, CA 92606 |
| Contact | John Carline |
| Correspondent | John Carline CARDIAC SCIENCE, INC. 16931 MILLIKAN AVE. Irvine, CA 92606 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-04 |
| Decision Date | 2003-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812394020935 | K022929 | 000 |
| 00812394020607 | K022929 | 000 |
| 00812394020256 | K022929 | 000 |