K190073 is an FDA 510(k) clearance for the Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).
Submitted by Current Health , Ltd. (Edinburgh, GB). The FDA issued a Cleared decision on March 27, 2019, 70 days after receiving the submission on January 16, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K190073 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2019 |
| Decision Date | March 27, 2019 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MSX - System, Network And Communication, Physiological Monitors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |