The following data is part of a premarket notification filed by Medtronic Emergency Response Systems, Inc. with the FDA for Lifenet Exchange System.
| Device ID | K052854 |
| 510k Number | K052854 |
| Device Name: | LIFENET EXCHANGE SYSTEM |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. 11811 WILLOWS RD., N.E. Redmond, WA 98052 |
| Contact | Teresa Davidson |
| Correspondent | Teresa Davidson MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. 11811 WILLOWS RD., N.E. Redmond, WA 98052 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-11 |
| Decision Date | 2006-01-20 |
| Summary: | summary |