K003579

Substantially Equivalent

NARKOMED MRI-2, MODEL NM-MRI-2

Applicant
Draeger Medical, Inc.
Product code
BSZ
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Telford, PA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code BSZ

product code BSZ
Death
23
Injury
298
Malfunction
32,987
Total
33,308

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.