NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON— 510(k) K910019
Substantially EquivalentNovametrix Medical Systems, Inc.
FDA 510(k) clearance K910019 for NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON, Substantially Equivalent on 1991-03-26. Applicant: Novametrix Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Novametrix Medical Systems, Inc.
- 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
- Wallingford, CT, US
Recent devices under product code CCK
view allMore clearances from Novametrix Medical Systems, Inc.
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.