The following data is part of a premarket notification filed by Medtronic Physio-control Corp. with the FDA for Medtronic Physio-control Lifepak 20 Defibrillator/monitor/pacemaker.
| Device ID | K012274 |
| 510k Number | K012274 |
| Device Name: | MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD NE P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Contact | Sherri L Pocock |
| Correspondent | Sherri L Pocock MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD NE P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-19 |
| Decision Date | 2002-02-05 |
| Summary: | summary |