DeviceClearance

K180206

Substantially Equivalent

neuromate Gen III

Applicant
Renishaw Mayfield Sarl
Product code
HAW
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Chassieu, FR
Download summary PDF View on FDA.gov ↗

Adverse events under product code HAW

product code HAW
Death
52
Injury
1,083
Malfunction
17,300
Total
18,435

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.