CARBONAID C02 DIFFUSER— 510(k) K112975
Substantially EquivalentCardia Innovation AB
FDA 510(k) clearance K112975 for CARBONAID C02 DIFFUSER, Substantially Equivalent on 2012-06-22. Applicant: Cardia Innovation AB. Device class: 2.
Clearance details
- Applicant
- Cardia Innovation AB
- Product code
- Code HIF
- Device class
- Class 2
- Regulation
- 21 CFR 884.1730
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Edina, MN, US
Recent devices under product code HIF
view allMore clearances from Cardia Innovation AB
view allAdverse events under product code HIF
product code HIF- Death
- 19
- Injury
- 578
- Malfunction
- 5,639
- Total
- 6,236
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.