DeviceClearance

K151080

Substantially Equivalent

Nihon Kohden CSM 1901 Bedside Monitor

Applicant
Nihon Kohden
Product code
MHX
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code MHX

product code MHX
Death
580
Injury
2,441
Malfunction
12,655
Other
3
Total
15,679

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.