GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076— 510(k) K992421

Name: FDA 510(k) clearance K992421
Creator: U.S. Food and Drug Administration
Published: 1999-10-27

Substantially Equivalent

Accutron, Inc.

FDA 510(k) clearance K992421 for GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076, Substantially Equivalent on 1999-10-27. Applicant: Accutron, Inc.. Device class: 2.

Clearance details

Applicant: Accutron, Inc.
Product code: Code BSZ
Device class: Class 2
Regulation: 21 CFR 868.5160
Advisory panel: Anesthesiology
Date received: 1999-07-21
Decision date: 1999-10-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Phoenix, AZ, 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.