K192732 is an FDA 510(k) clearance for the BodyGuardian Remote Monitoring System. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Preventice Technologies, Inc. (Rochester, US). The FDA issued a Cleared decision on March 26, 2020, 181 days after receiving the submission on September 27, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K192732 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2019 |
| Decision Date | March 26, 2020 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSI - Detector And Alarm, Arrhythmia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |