E-Cath— 510(k) K152952

Substantially Equivalent

PAJUNK GmbH Medizintechnologie

FDA 510(k) clearance K152952 for E-Cath, Substantially Equivalent on 2016-07-13. Applicant: PAJUNK GmbH Medizintechnologie.

Clearance details

Applicant: PAJUNK GmbH Medizintechnologie
Product code: Code BSO
Advisory panel: Anesthesiology
Date received: 2015-10-06
Decision date: 2016-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geisingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.