K221046 is an FDA 510(k) clearance for the Invu by Nuvo. This device is classified as a Home Uterine Activity Monitor (Class II - Special Controls, product code LQK).
Submitted by Nuvo- Group , Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on May 6, 2022, 28 days after receiving the submission on April 8, 2022.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2730.
| 510(k) Number | K221046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 2022 |
| Decision Date | May 06, 2022 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | LQK - Home Uterine Activity Monitor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2730 |