Cleared Abbreviated

PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50

K111083 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Obstetrics & Gynecology
Aug 2011
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K111083 is an FDA 510(k) clearance for the PHILIPS AVALON FETAL/MATERNAL MONITORS FM20, FM30, FM40 AND FM50, 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 August 17, 2011, 120 days after receiving the submission on April 19, 2011. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2740.

Submission Details

510(k) Number K111083 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2011
Decision Date August 17, 2011
Days to Decision 120 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HGM — System, Monitoring, Perinatal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.2740

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