NEO-STAT CO2 <KG— 510(k) K083056
Substantially EquivalentMercury Medical
FDA 510(k) clearance K083056 for NEO-STAT CO2 <KG, Substantially Equivalent on 2009-02-23. Applicant: Mercury Medical. Device class: 2.
Clearance details
- Applicant
- Mercury Medical
- Product code
- Code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bonita Springs, FL, US
Recent devices under product code CCK
view allMore clearances from Mercury Medical
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.