BIVONA VENTILATOR ISOLATOR SYSTEM— 510(k) K890499

Substantially Equivalent

Bivona Medical Technologies

FDA 510(k) clearance K890499 for BIVONA VENTILATOR ISOLATOR SYSTEM, Substantially Equivalent on 1989-06-15. Applicant: Bivona Medical Technologies.

Clearance details

Applicant: Bivona Medical Technologies
Product code: Code CAI
Advisory panel: Anesthesiology
Date received: 1989-02-01
Decision date: 1989-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gary, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 870

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.