FDA 510(k) Applications for Medical Device Product Code "LQK"
(Home Uterine Activity Monitor)

FDA 510(k) Number Applicant Device Name Decision Date
K143114 AIRSTRIP TECHNOLOGIES, INC. Sense4Baby System Model B+ (MSA) 03/10/2015
K020390 HUNTLEIGH DIAGNOSTICS LTD. MODIFICATION TO FETAL ASSIST 04/19/2002
K221046 Nuvo- Group Ltd. Invu by Nuvo 05/06/2022
K210025 Nuvo-Group Ltd. INVU by Nuvo 05/28/2021
K191401 Nuvo-Group Ltd. PregSense 03/27/2020


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