Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)— 510(k) K233440

Substantially Equivalent

Philips Medizin Systeme Boeblingen GmbH

FDA 510(k) clearance K233440 for Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341), Substantially Equivalent on 2024-07-02. Applicant: Philips Medizin Systeme Boeblingen GmbH.

Clearance details

Applicant: Philips Medizin Systeme Boeblingen GmbH
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2023-10-18
Decision date: 2024-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boeblingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.