K822656

Substantially Equivalent

C-200 INFANT INCUBATOR

Applicant
Narco Scientific
Product code
FMZ
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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, 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.