VENTRAIN— 510(k) K132759

Substantially Equivalent

Dolphys Medical B.V.

FDA 510(k) clearance K132759 for VENTRAIN, Substantially Equivalent on 2014-03-26. Applicant: Dolphys Medical B.V..

Clearance details

Applicant: Dolphys Medical B.V.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2013-09-04
Decision date: 2014-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eindhoven, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.