TIDAL VOLUME MONITOR 150— 510(k) K812046

Substantially Equivalent

Medix Medical Electronics (U.S.A.), Inc.

FDA 510(k) clearance K812046 for TIDAL VOLUME MONITOR 150, Substantially Equivalent on 1981-08-07. Applicant: Medix Medical Electronics (U.S.A.), Inc..

Clearance details

Applicant: Medix Medical Electronics (U.S.A.), Inc.
Product code: Code BZK
Advisory panel: Anesthesiology
Date received: 1981-07-21
Decision date: 1981-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BZK

product code BZK

Death: 2
Total: 2

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.