510(k) K233440

Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) by Philips Medizin Systeme Boeblingen GmbH — Product Code HGM

K233440 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boeblingen GmbH for the device "Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)". The FDA issued a decision of Substantially Equivalent on July 2, 2024. The device falls under product code HGM (System, Monitoring, Perinatal), a Class II device regulated under 21 CFR 884.2740. Philips Medizin Systeme Boeblingen GmbH has at least 10 other 510(k) clearances on record.