NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847— 510(k) K982969
Substantially EquivalentNonin Medical, Inc.
FDA 510(k) clearance K982969 for NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847, Substantially Equivalent on 1999-08-12. Applicant: Nonin Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Nonin Medical, 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
- Plymouth, MN, US
Recent devices under product code CCK
view allMore clearances from Nonin Medical, 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.