K011586

Substantially Equivalent

IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE

Applicant: Diametrics Medical, Inc.
Product code: GAA
Advisory panel: General, Plastic Surgery
Date received: 2001-05-23
Decision date: 2001-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roseville, MN, US

Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.