DeviceClearance

K974396

Substantially Equivalent

IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE

Applicant
Diametrics Medical, Inc.
Product code
CHL
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Roseville, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code CHL

product code CHL
Death
20
Malfunction
999
Total
1,019

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.