NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR— 510(k) K931542

Name: FDA 510(k) clearance K931542
Creator: U.S. Food and Drug Administration
Published: 1993-10-25

Substantially Equivalent

Newport Medical Instruments, Inc.

FDA 510(k) clearance K931542 for NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR, Substantially Equivalent on 1993-10-25. Applicant: Newport Medical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Newport Medical Instruments, Inc.
Product code: Code BZK
Device class: Class 2
Regulation: 21 CFR 868.1850
Advisory panel: Anesthesiology
Date received: 1993-03-29
Decision date: 1993-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

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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.