PHILIPS OBTRACEVUE MODEL SW REV. G.00— 510(k) K100420

Substantially Equivalent

Philips Medizin Systeme Boeblingen GmbH

FDA 510(k) clearance K100420 for PHILIPS OBTRACEVUE MODEL SW REV. G.00, Substantially Equivalent on 2010-07-26. Applicant: Philips Medizin Systeme Boeblingen GmbH.

Clearance details

Applicant: Philips Medizin Systeme Boeblingen GmbH
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2010-02-16
Decision date: 2010-07-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Boeblingen, DE

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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.