The following data is part of a premarket notification filed by Medtronic Emergency Response Systems, Inc. with the FDA for Lifepak 12 Defibrillator/monitor.
| Device ID | K063510 |
| 510k Number | K063510 |
| Device Name: | LIFEPAK 12 DEFIBRILLATOR/MONITOR |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. 11811 WILLOWS RD., N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Contact | Michelle Ackermann |
| Correspondent | Michelle Ackermann MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. 11811 WILLOWS RD., N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Product Code | MKJ |
| Subsequent Product Code | CCK |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRO |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | LDD |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-20 |
| Decision Date | 2007-01-26 |
| Summary: | summary |