CARBONAID C02 DIFFUSER— 510(k) K112975

Substantially Equivalent

Cardia Innovation AB

FDA 510(k) clearance K112975 for CARBONAID C02 DIFFUSER, Substantially Equivalent on 2012-06-22. Applicant: Cardia Innovation AB.

Clearance details

Applicant: Cardia Innovation AB
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2011-10-05
Decision date: 2012-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edina, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.