IntelliSpace Perinatal Rev.K.00— 510(k) K173941

Substantially Equivalent

Philips Medizin Systeme Boeblingen GmbH

FDA 510(k) clearance K173941 for IntelliSpace Perinatal Rev.K.00, Substantially Equivalent on 2018-09-10. Applicant: Philips Medizin Systeme Boeblingen GmbH.

Clearance details

Applicant: Philips Medizin Systeme Boeblingen GmbH
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2017-12-26
Decision date: 2018-09-10
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.