510(k) K100121— MODEL 300157 CPAP SYSTEM

Substantially Equivalent

Aeiomed, Inc.

Clearance details

Applicant: Aeiomed, Inc.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2010-01-15
Decision date: 2010-07-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Minneapolis, MN, US

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.