The following data is part of a premarket notification filed by Medtronic Physio-control Corp. with the FDA for Infant/child Reduced Energy Electrodes.
| Device ID | K022732 |
| 510k Number | K022732 |
| Device Name: | INFANT/CHILD REDUCED ENERGY ELECTRODES |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD., N.E. Redmond, WA 98073 |
| Contact | Sherri L Pocock |
| Correspondent | Sherri L Pocock MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD., N.E. Redmond, WA 98073 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-16 |
| Decision Date | 2002-12-13 |
| Summary: | summary |