The following data is part of a premarket notification filed by Physio-control, Inc. with the FDA for Lifepak 20 Defibrillator/monitor, Lifepak 20e Defibrillator/monitor.
| Device ID | K130454 |
| 510k Number | K130454 |
| Device Name: | LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHYSIO-CONTROL, INC. 11811 WILLOWS ROAD NORTHEAST P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Contact | Michelle Ackermann |
| Correspondent | Michelle Ackermann PHYSIO-CONTROL, INC. 11811 WILLOWS ROAD NORTHEAST P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-22 |
| Decision Date | 2013-08-21 |
| Summary: | summary |