The following data is part of a premarket notification filed by Preventice, Inc. with the FDA for Bodyguardian System Bodyguardian Control Unit Bodyguardian Connect.
| Device ID | K121197 |
| 510k Number | K121197 |
| Device Name: | BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | PREVENTICE, INC. 2765 COMMERCE DRIVE NW SUITE 220 Rochester, MN 55901 |
| Contact | Drew Palin |
| Correspondent | Drew Palin PREVENTICE, INC. 2765 COMMERCE DRIVE NW SUITE 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 | 2012-04-19 |
| Decision Date | 2012-08-10 |
| Summary: | summary |