STURDY MANUAL RESUSCITATOR— 510(k) K032596

Name: FDA 510(k) clearance K032596
Creator: U.S. Food and Drug Administration
Published: 2004-08-05

Substantially Equivalent

Sturdy Industrial Co., Ltd.

FDA 510(k) clearance K032596 for STURDY MANUAL RESUSCITATOR, Substantially Equivalent on 2004-08-05. Applicant: Sturdy Industrial Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sturdy Industrial Co., Ltd.
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 2003-08-22
Decision date: 2004-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.