About This 510(k) Submission
K232893 is an FDA 510(k) clearance for the Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F), a Monitor, Ultrasonic, Fetal (Class II — Special Controls, product code KNG), submitted by Contec Medical Systems Co.,Ltd (Qinhuangdao, CN). The FDA issued a Cleared decision on June 14, 2024, 270 days after receiving the submission on September 18, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2660.