The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Lifepak 10 Defibrillator/monitor/pacemaker, And Lifepak 11 Cardiac Monitor.
| Device ID | K945511 |
| 510k Number | K945511 |
| Device Name: | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR |
| Classification | Auxiliary Power Supply (acor Dc) For External Transcutaneous Cardiac Pacemaker |
| Applicant | PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Contact | Michael D Willingham |
| Correspondent | Michael D Willingham PHYSIO-CONTROL CORP. 11811 WILLOWS RD. N.E. P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Product Code | MPE |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-09 |
| Decision Date | 1995-09-26 |