The following data is part of a premarket notification filed by Physio-control, Inc. with the FDA for Lifepak 15 Monitor/defibrillator.
| Device ID | K103567 |
| 510k Number | K103567 |
| Device Name: | LIFEPAK 15 MONITOR/DEFIBRILLATOR |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHYSIO-CONTROL, INC. 11811 WILLOWS RD., N.E. Redmond, WA 98052 |
| Contact | Michelle Ackermann |
| Correspondent | Michelle Ackermann PHYSIO-CONTROL, INC. 11811 WILLOWS RD., N.E. Redmond, WA 98052 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-06 |
| Decision Date | 2011-03-22 |
| Summary: | summary |