K190916 is an FDA 510(k) clearance for the VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20. This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by Vitalconnect, Inc. (San Jose, US). The FDA issued a Cleared decision on June 7, 2019, 59 days after receiving the submission on April 9, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K190916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2019 |
| Decision Date | June 07, 2019 |
| Days to Decision | 59 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 |