NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60— 510(k) K915494
Substantially EquivalentNellcor, Inc.
FDA 510(k) clearance K915494 for NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60, Substantially Equivalent on 1993-08-06. Applicant: Nellcor, Inc.. Device class: 2.
Clearance details
- Applicant
- Nellcor, 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
- Hayward, CA, US
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Adverse 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.