DeviceClearance

K230278

Substantially Equivalent

Babyroo TN300

Applicant
Draeger Medical Systems, Inc.
Product code
FMT
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Telford, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code FMT

product code FMT
Death
4
Malfunction
3,074
Total
3,078

Source: openFDA MAUDE database, through . 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.