ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.— 510(k) K060657

Substantially Equivalent

Breas Medical AB

FDA 510(k) clearance K060657 for ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20., Substantially Equivalent on 2006-08-18. Applicant: Breas Medical AB.

Clearance details

Applicant: Breas Medical AB
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2006-03-13
Decision date: 2006-08-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Molnlycke, SE

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Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.