BREAS, MODEL HA01— 510(k) K060790

Name: FDA 510(k) clearance K060790
Creator: U.S. Food and Drug Administration
Published: 2006-05-25

Substantially Equivalent

Breas Medical AB

FDA 510(k) clearance K060790 for BREAS, MODEL HA01, Substantially Equivalent on 2006-05-25. Applicant: Breas Medical AB. Device class: 2.

Clearance details

Applicant: Breas Medical AB
Product code: Code BTT
Device class: Class 2
Regulation: 21 CFR 868.5450
Advisory panel: Anesthesiology
Date received: 2006-03-23
Decision date: 2006-05-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Molnlycke, SE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.