K163453 is an FDA 510(k) clearance for the VitalPatch® VitalConnect Platform. This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by Vitalconnect, Inc. (Campbell, US). The FDA issued a Cleared decision on November 2, 2017, 328 days after receiving the submission on December 9, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K163453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2016 |
| Decision Date | November 02, 2017 |
| Days to Decision | 328 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2910 |