The following data is part of a premarket notification filed by Preventice Technologies, Inc. with the FDA for Bodyguardian Remote Monitoring System.
| Device ID | K192732 |
| 510k Number | K192732 |
| Device Name: | BodyGuardian Remote Monitoring System |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | Preventice Technologies, Inc. 3052 Hwy52 N, Building 003-2 Rochester, MN 55901 |
| Contact | Charles Rector |
| Correspondent | Charles Rector Preventice Technologies, Inc. 3052 Hwy52 N, Building 003-2 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 | 2019-09-27 |
| Decision Date | 2020-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852132007309 | K192732 | 000 |
| 00852132007286 | K192732 | 000 |