SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE— 510(k) K863703
Substantially EquivalentSalter Labs
FDA 510(k) clearance K863703 for SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE, Substantially Equivalent on 1986-10-15. 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
view allMore clearances from Salter Labs
view all- K261389 — PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
- K161719 — Salter Labs Bubble Humidifier
- K151874 — BiNAPS Nasal Airflow and Snore Transducer +1 more
- 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.