UNIVERSAL JET VENTILATOR MODEL AMS-1000— 510(k) K863155

Substantially Equivalent

Acutronic Medical Systems AG

FDA 510(k) clearance K863155 for UNIVERSAL JET VENTILATOR MODEL AMS-1000, Substantially Equivalent on 1987-09-28. Applicant: Acutronic Medical Systems AG.

Clearance details

Applicant: Acutronic Medical Systems AG
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 1986-08-15
Decision date: 1987-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jona-Rapper Swril, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.