IRMA C02 MODEL 200101; IRMA AX 200601— 510(k) K123043
Substantially EquivalentPhasein AB
FDA 510(k) clearance K123043 for IRMA C02 MODEL 200101; IRMA AX 200601, Substantially Equivalent on 2012-10-25. Applicant: Phasein AB. Device class: 2.
Clearance details
- Applicant
- Phasein AB
- Product code
- Product code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Madison, WI, US
Recent devices under product code CCK
view allMore clearances from Phasein AB
view allAdverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
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.