The following data is part of a premarket notification filed by Medtronic Physio-control Corp. with the FDA for Lifepak 12, 20, 500, Cr Plus.
| Device ID | K033275 |
| 510k Number | K033275 |
| Device Name: | LIFEPAK 12, 20, 500, CR PLUS |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD NE P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Contact | Michelle Ackermann |
| Correspondent | Michelle Ackermann MEDTRONIC PHYSIO-CONTROL CORP. 11811 WILLOWS RD NE P.O. BOX 97006 Redmond, WA 98073 -9706 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-10 |
| Decision Date | 2003-11-06 |
| Summary: | summary |