The following data is part of a premarket notification filed by Physio-control, Inc. with the FDA for Lifepak 15 Monitor/defibrillator.
| Device ID | K082937 |
| 510k Number | K082937 |
| Device Name: | LIFEPAK 15 MONITOR/DEFIBRILLATOR |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | PHYSIO-CONTROL, INC. 11811 WILLOWS RD., N.E. PO BOX 97006 Redmond, WA 98052 |
| Contact | Teresa Davidson |
| Correspondent | Teresa Davidson PHYSIO-CONTROL, INC. 11811 WILLOWS RD., N.E. PO BOX 97006 Redmond, WA 98052 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-01 |
| Decision Date | 2009-03-11 |
| Summary: | summary |