The following data is part of a premarket notification filed by Medtronic Physio-control Corp. with the FDA for Lifepak 12defiberllator/monitor Series.
| Device ID | K002445 |
| 510k Number | K002445 |
| Device Name: | LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD., N.E. Redmond, WA 98073 |
| Contact | Bob Zito |
| Correspondent | Bob Zito MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD., N.E. Redmond, WA 98073 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-09 |
| Decision Date | 2001-01-31 |