The following data is part of a premarket notification filed by Medtronic Physio-control Corp. with the FDA for Lifepak 12 Defibrillator/monitor System.
| Device ID | K010918 |
| 510k Number | K010918 |
| Device Name: | LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM |
| 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 |
| Subsequent Product Code | LDD |
| Subsequent Product Code | MWI |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-27 |
| Decision Date | 2001-08-23 |