Babyleo TN500— 510(k) K162821

Substantially Equivalent

Draegerwerk AG & CO Kgaa

FDA 510(k) clearance K162821 for Babyleo TN500, Substantially Equivalent on 2017-06-23. Applicant: Draegerwerk AG & CO Kgaa.

Clearance details

Applicant: Draegerwerk AG & CO Kgaa
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 2016-10-07
Decision date: 2017-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lübeck, DE

Download summary PDF View on FDA.gov ↗

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.