ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT— 510(k) K915226

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K915226 for ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT, Substantially Equivalent on 1993-01-12. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code BZE
Advisory panel: Anesthesiology
Date received: 1991-11-20
Decision date: 1993-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZE

product code BZE

Death: 4
Malfunction: 910
Other: 1
Total: 915

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.