Cleared Traditional

Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)

K233440 · Philips Medizin Systeme Boeblingen GmbH · Obstetrics & Gynecology
Jul 2024
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K233440 is an FDA 510(k) clearance for the Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341), a System, Monitoring, Perinatal (Class II — Special Controls, product code HGM), submitted by Philips Medizin Systeme Boeblingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on July 2, 2024, 258 days after receiving the submission on October 18, 2023. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.2740.

Submission Details

510(k) Number K233440 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2023
Decision Date July 02, 2024
Days to Decision 258 days
Submission Type Traditional
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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