BREAS ISLEEP 20I— 510(k) K063476

Substantially Equivalent

Breas Medical AB

FDA 510(k) clearance K063476 for BREAS ISLEEP 20I, Substantially Equivalent on 2007-01-22. Applicant: Breas Medical AB.

Clearance details

Applicant: Breas Medical AB
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2006-11-16
Decision date: 2007-01-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Molnlycke, SE

Download summary PDF View on FDA.gov ↗

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.