About This 510(k) Submission
K173042 is an FDA 510(k) clearance for the Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3, a System, Monitoring, Perinatal (Class II — Special Controls, product code HGM), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on August 30, 2018, 336 days after receiving the submission on September 28, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2740.