MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.— 510(k) K864902
Substantially EquivalentSalter Labs
FDA 510(k) clearance K864902 for MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU., Substantially Equivalent on 1987-01-28. Applicant: Salter Labs. Device class: 2.
Clearance details
- Applicant
- Salter Labs
- 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
- Arvin, CA, US
Recent devices under product code CCK
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- K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
- K151421 — Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
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.