About This 510(k) Submission
K071800 is an FDA 510(k) clearance for the PHILIPS AVALON FETAL MONITORS FM20 AND FM30, a System, Monitoring, Perinatal (Class II — Special Controls, product code HGM), submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on September 27, 2007, 87 days after receiving the submission on July 2, 2007. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2740.