The following data is part of a premarket notification filed by Preventice with the FDA for Bodyguardian Remote Monitoring System.
| Device ID | K151188 |
| 510k Number | K151188 |
| Device Name: | BodyGuardian Remote Monitoring System |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | PREVENTICE 2765 COMMERCE DRIVE NW, #220 Rochester, MN 55901 |
| Contact | Charlie Rector |
| Correspondent | Charlie Rector PREVENTICE 2765 COMMERCE DRIVE NW, #220 Rochester, MN 55901 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-04 |
| Decision Date | 2015-09-17 |
| Summary: | summary |