SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504— 510(k) K982225

Name: FDA 510(k) clearance K982225
Creator: U.S. Food and Drug Administration
Published: 1998-10-28

Substantially Equivalent

Spiracle Technology

FDA 510(k) clearance K982225 for SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504, Substantially Equivalent on 1998-10-28. Applicant: Spiracle Technology. Device class: 2.

Clearance details

Applicant: Spiracle Technology
Product code: Code BTL
Device class: Class 2
Regulation: 21 CFR 868.5925
Advisory panel: Anesthesiology
Date received: 1998-06-24
Decision date: 1998-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fountain Valley, CA, US

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Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.