The following data is part of a premarket notification filed by Medtronic Emergency Response Systems, Inc. with the FDA for Lifepak 500 Automated External Defibrillator.
| Device ID | K052057 |
| 510k Number | K052057 |
| Device Name: | LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. 11811 WILLOWS RD., N.E. PO BOX 97006 Redmond, WA 98073 |
| Contact | Sherri Pocock |
| Correspondent | Sherri Pocock MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. 11811 WILLOWS RD., N.E. PO BOX 97006 Redmond, WA 98073 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-29 |
| Decision Date | 2006-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00681490576154 | K052057 | 000 |
| 00681490576345 | K052057 | 000 |