K182859

Substantially Equivalent

Babyleo TN500

Applicant: Dragerwerk AG & CO Kgaa
Product code: FMZ
Advisory panel: General Hospital
Date received: 2018-10-11
Decision date: 2019-02-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Lübeck, DE

Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

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.