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LQK — Home Uterine Activity Monitor Class II

FDA Device Classification

Classification Details

Product Code
LQK
Device Class
Class II
Regulation Number
884.2730
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K221046nuvo- groupInvu by NuvoMay 6, 2022
K210025nuvo- groupINVU by NuvoMay 28, 2021
K191401nuvo- groupPregSenseMarch 27, 2020
K143114airstrip technologiesSense4Baby System Model B+ (MSA)March 10, 2015
K020390huntleigh diagnosticsMODIFICATION TO FETAL ASSISTApril 19, 2002