K143114 is an FDA 510(k) clearance for the Sense4Baby System Model B+ (MSA). This device is classified as a Home Uterine Activity Monitor (Class II - Special Controls, product code LQK).
Submitted by Airstrip Technologies, Inc. (La Jolla, US). The FDA issued a Cleared decision on March 10, 2015, 131 days after receiving the submission on October 30, 2014.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2730.
| 510(k) Number | K143114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2014 |
| Decision Date | March 10, 2015 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| 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 |