BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000— 510(k) K041430

Name: FDA 510(k) clearance K041430
Creator: U.S. Food and Drug Administration
Published: 2004-10-07

Substantially Equivalent

Blease Medical Equipment , Ltd.

FDA 510(k) clearance K041430 for BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000, Substantially Equivalent on 2004-10-07. Applicant: Blease Medical Equipment , Ltd.. Device class: 2.

Clearance details

Applicant: Blease Medical Equipment , Ltd.
Product code: Code BSZ
Device class: Class 2
Regulation: 21 CFR 868.5160
Advisory panel: Anesthesiology
Date received: 2004-05-28
Decision date: 2004-10-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Appollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.